Medical Devices

EU Regulation 2017/745 on medical devices and active implantable medical devices (MDR) and Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) introduce safety and vigilance obligations similar to those for pharmaceuticals.

Due to COVID-19, application of the MDR – initially planned for 26 May 2020 – was postponed to 26 May 2021. Also, the IVDR has finally been applied, starting on 26 May 2022.

Based on Article 15 of Law 53/2021, the Italian government is in the process of adopting legislative decrees to modify the national regulations on medical devices and in vitro medical devices to comply with the MDR and IVDR.

On 5 May 2022, the Council of Ministers approved the draft legislative decrees for the adaptation of Italian regulations to the MDR and IVDR. However, the text of these two legislative decrees must complete the legislative process in order to be published in the Official Gazette.

On 12 November 2021, the Ministry of Heath issued a note providing guidance on certain aspects of the MDR, such as advertising, sanctions and notified bodies.

The MDR reinforces safety standards of medical devices. Compared to the previous Italian legal framework (ie, Legislative Decree 47/96), different classes of risks are introduced with different pre-marketing steps/approval processes. In October 2021, the Medical Device Coordination Group (MDCG) published the “Guidance on classification of medical devices” in the light of the MDR.

A new traceability system was introduced with the so-called Unique Device Identifier code (UDI).

The aforementioned Regulations introduce a new European database of medical devices (EUDAMED) in order to help sharing on a single platform all information related to such devices marketed in Europe. With the Implementing Regulation (EU) 2021/2078, the Commission laid down the detailed arrangements necessary for setting up EUDAMED.

With regard to software-based medical devices, the “MEDDEV 2.1/6 Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices”, issued by the EU Commission in July 2016, and the “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”, issued in October 2019 by the MDCG, apply. They provide indications on the classification of risk class applicable to software and apps based on their characteristics and interactions.

Pharmaceuticals

Legislative Decree 219/2006 (Medicinal Product Code) provides that medicinal products cannot be placed on the market without an authorisation from the Italian Drug Agency (AIFA) or an EU authorisation from the European Medicine Agency (EMA) in accordance with EU Regulation 726/2004.

No one can manufacture medicinal products on the Italian territory without a manufacturing authorisation from the AIFA, issued after an inspection.

The pharmacovigilance "responsible person" must meet certain professional requirements and comply with obligations such as submission of periodic reports on product safety (PSURs).

PSURs are not required for generic, homeopathic, traditional herbal medicinal products or products based on substances which have a well-established medicinal use.

Blood Products

Industrial blood products are medicines produced through industrial manufacturing processes from human blood or plasma derived from voluntary donations.

Blood products must obtain a marketing authorisation as per Legislative Decree 219/2006 pursuant to assessment of quality, safety and efficacy.

Law 219/2005 sets out basic rules for the national production of blood products.

Personal Protection Equipment

Personal Protection Equipment (PPE) are designed to be worn or held by an individual for protection against safety hazards. PPE must comply with requirements provided under EU Regulation 425/2016 (PPE Regulation). All PPE must meet Essential Health and Safety Requirements (EHSR) and must be CE-marked.

PPE are classified into three risk categories (Annex I).

Medical Instruments

Medical instruments are a broad category that include surgery instruments, ER instruments, invasive, non-invasive medical diagnostics instruments and, in general, all those instruments used in a medical environment to diagnose, cure, treat, prevent diseases or help/support such purposes – eg, stethoscopes, electrocardiographs and syringes.

The intended purpose helps in determining whether a medical instrument is considered a medical device or not. If the instrument was manufactured to be used for one of the medical purposes listed in Article 2(1) MDR or Article 2(2) IVDR, then it is a medical device.

Cosmetics

EU Regulation 1223/2009 concerns cosmetic products. EU Regulation 1099/2021, EU Regulation 1902/2021 and EU Regulation 135/2022, which added further banned substances to the composition of cosmetics, recently amended it.

Its basic principle is that, to ensure the safety of cosmetic products, a “responsible person” must be designated within the EU to place the products on the market. Such responsible person is usually the manufacturer or a person designated in writing by the manufacturer acting on its behalf.

For cosmetics imported into the EU, the importer is considered the responsible person. The distributor can also be considered the responsible person in specific cases.

Biocides

EU Regulation 528/2012 concerns the making available on the market and use of biocidal products (Biocidal Products Regulation, BPR).

Biocidal products cannot be placed on the market or used without authorisation pursuant to the BPR. National authorisation, a European centralised authorisation (for certain types of biocides) or a mutual recognition procedure are available.

Active substances of a biocidal product must also be pre-approved.

Transitioning to full implementation of the BPR, in Italy products containing active substances currently under review in accordance with BPR requirements can be placed on the market as per Presidential Decree 392/1998 as Presidi medico-chirurgici by submitting an application for a marketing authorisation to the Ministry of Health and National Institute of Health (ISS).

In the case of breach of the provisions of the BPR, the sanctions provided for in Legislative Decree 179/2021 shall apply.

Food and Nutrition Supplements

Regulation 178/2002 reinforces the rules on safety of food in the EU. The basic principle is that no food dangerous to health or unfit for consumption may be put on sale in the EU.

EU Regulation 1169/2011 establishes general principles, requirements and responsibilities governing food information and labelling.

Mandatory food information falls into the following categories:

• identity and composition, properties, and other characteristics of food;
• protection of consumers’ health and safe use of a food; and
• nutritional characteristics.

Legislative Decree 231/2017 provides sanctions with respect to violations of EU Regulation 1169/2011.

EU Regulation 625/2017 sets common rules for official controls to ensure that agricultural food chain legislation to protect human health, animal health and welfare and plant health is correctly applied and enforced.

EU Directive 46/2002 concerns food supplements; it has been implemented with Legislative Decree 169/2004.

The commercialisation of food supplements in Italy is subject to a label notification procedure to the Ministry of Health.

Genetically modified organisms (GMOs) in food are regulated by European legislation. In particular, EU Regulation 1829/2003 regulates the placing on the market of products intended for food or feed containing GMOs as well as the labelling of products intended for the final consumer, while EU Regulation 1830/2003 establishes a harmonised community system to ensure the traceability and labelling of GMOs and the traceability of products intended for food or feed produced from GMOs.

Medical Apps

Mobile applications are often used in connection with so-called wearable devices. Some of those apps, such as health and lifestyle apps, fall under the category of “mobile health” or “mHealth”.

Some of these mHealth apps may qualify as medical devices and will have to be CE-marked and follow the MDR.

To determine whether an mHealth app is a medical device, the fact that an app for generic purposes is used in a health-related field is not sufficient. In general, apps that perform an action limited to storage, archival, communication, simple search (so-called library functions) are not considered medical devices. While the discriminant is the “intended purpose”, whether the app has been intended by the developer to be used for one of the medical purposes listed in the MDR. In such a case, the mHealth app is considered a medical device.

“MEDDEV 2.1/6 Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices”, issued by the EU Commission in July 2016, and the “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”, issued in October 2019 by MDCG, provide indications on the classification of risk class applicable to software and apps based on their characteristics and interactions.

Telemedicine

On 17 December 2020 "National Guidelines for the provision of telemedicine services" were approved by the State-Regions Conference. Such guidelines represent, so far, the reference document for implementation of telemedicine services under the NHS. They list the services that can be provided through telemedicine, also taking into account cybersecurity profiles and patients' consent.

On 18 November 2021, the State-Regions Conference adopted a document containing the “Guidelines for the provision of telerehabilitation services by the health professions”.

Moreover, the PNRR is promoting the development of telemedicine services. For instance, on 29 April 2022 the Ministry of Health issued a decree providing the “Organisational Guidelines containing the Digital Model for the Implementation of Home Care”.

Wearables

Wearable electronic devices are meant to interact and be worn in contact with the human body. They are part of the broader category of wearables.

Wearables are part of the Internet of Things, and are usually connected wirelessly with other devices (eg, smartphones). The popularity of wearables is due to their use for fitness and well-being purposes.

Whether a wearable is a medical device or not depends on the “intended purpose”, whether it has been intended by the manufacturer to be used for one of the medical purposes listed in Article 2(1) MDR or Article 2(2) IVDR. If this is the case, then the wearable is a medical device and is subject to regulatory approvals, safety requirements and post-market surveillance requirements set forth therein.

CBD (Cannabidiol)

As one of the active ingredients of cannabis with no psychotropic effect, CBD is not per se considered illegal. However, cultivation and commercialisation of cannabis-derivative products is in general forbidden in Italy as cannabis and its derivatives (such as oil, resins and leaves) are included in the tables of the narcotic and psychotropic substances of the Decree of President of the Republic 309/1990, (the "Narcotic and Psychotropic Drugs Code").

Law 242/2016 allowed the cultivation of a type of cannabis (ie, Cannabis Sativa L) without authorisation only in order to obtain certain derivative products which are specifically listed, such as:

• food and cosmetics produced exclusively in compliance with the disciplines of the respective sectors; and
• semi-finished products, such as fiber, sheaves, powders, wood chips, oils or gasoline, for supplies to industries and artisan activities from different sectors.

Such cultivation is allowed to the extent the concentration of THC in cannabis is not higher than 0.6%. Except for this limited exemption, cannabis falls under the Narcotic and Psychotropic Drugs Code as a narcotic or psychotropic substance.

Cannabis use (even with a THC concentration of higher than 0.6%) is however allowed for therapeutic purposes upon non-repeatable prescription and taking into consideration the specific condition of the patient.

Borderline Products

“Borderline products” are those not easily classifiable since they can be confused with other classes of products.

Typical borderline products are devices and medicinal products whereby a device contains a substance which, if used separately, would be classified as a medicinal product.

To be a medical device, a product must fulfil the definition given by the MDR, which provides two main elements for considering a product as a medical device:

• the specific medical purpose; and
• the principal intended action.

The specific medical purpose is as defined in the MDR, while the principal intended action must be achieved through a mode of action other than pharmacological, immunological or metabolic means.

The function of a medical device is achieved by physical means, including mechanical functions or replacement/support to organs or body functions.

The medical device guidelines (MEDDEV) 2. 1/3 rev 3 on “Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative” provide clear definitions of pharmacological, immunological and metabolic means and examples of products that, although borderline, are either medical devices or medicinal products. Moreover, on April 2022, the MDCG published “Guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices”.

The MDR provides that any device which incorporates, as an integral part, a substance which, if used separately, would be considered a medicinal product and has an action ancillary to that of the device is assessed and authorised in accordance with the MDR.

From a risk class perspective, all devices incorporating a medicinal product with ancillary function are classified as Class III.

A different conclusion on classification of the product is when a device and a medicinal product are placed on the market as a single integral product intended exclusively for use in the given combination and not reusable (eg, pre-filled syringes, aerosols containing a medicinal product). These products are governed by EU Directive 83/2001 or EU Regulation 726/2004, as applicable.

Neither cosmetics nor food supplements can be considered medicinal products.

Food supplements may contain as ingredients substances also used as active ingredients in some medicinal products. The EU Commission identified few criteria to distinguish a food supplement from a medicinal product (despite the common ingredient).

Another category of borderline products is medical devices/PPE. The main difference is that the purpose of PPE is to protect the wearer from safety hazards, while the purpose of the medical device is to guarantee, protect and support the health of a person other than the wearer, namely the patient. 

Difficulties concerning the distinction between medicines and food may arise. National authorities are competent to classify a product as medicine or food on a case-by-case basis. The European Court of Justice also plays a major role in defining the criteria for classifying a product as a food, food supplement, or medicinal product.

Borderline products issues may concern herbal medicinal products and herbal supplements. In Italy, Legislative Decree 219/2006 regulates herbal medicines.

Medicinal Products

To manufacture medicinal products, the manufacturer must hold a manufacturing licence granted by AIFA. All manufacturing operations must take place at authorised sites.

AIFA grants manufacturing authorisation upon inspection of the site to ensure compliance with good manufacturing practices set by EU Directive 94/2003 (GMPs). The authorisation procedure takes 90 days.

The qualified person (QP) must hold certain educational and professional requirements. The QP guarantees compliance of batches manufactured at the site with applicable laws and conditions imposed by the competent authority.

Medical Devices

Under the MDR, manufacturers must manufacture devices in accordance with the general safety and performance requirements of Annex I. The application for validation of the quality management system must include the name of the manufacturer and the address of its place of business and any additional sites covered by the quality management system, and, if the manufacturer's application is filed by its authorised representative, the name and address of the authorised representative.

One regulatory compliance person needs to be appointed to, among other obligations, check compliance of the manufacturing process with the quality management system before release of a device.

Manufacturers are also subject to certain registration requirements in the UDI Database, the EUDAMED and the Commission electronic system to obtain the release of a single registration number to identify the manufacturer and, if applicable, its authorised representative or importer.

Competent authorities perform periodic audits of the quality management system of the manufacturer including on-site audits.

Blood Products

Manufacturing sites authorised to produce blood products must have an appropriate size, advanced technology and can manufacture only those products included in the framework agreements stipulated with regions and provinces.

Manufacturers must demonstrate that validated production and purification processes allow to constantly obtain homogeneous batches and guarantee, as far as permitted by technical developments, the absence of transmissible viral contaminants or pathogens.

Manufacturing sites must keep adequate documentation to go back from the final product to the initial blood donations from which the final blood product derives. Moreover, manufacturing sites for each and any batches of hemoderivatives must be in possession of documentation proving the origin of the plasma treated and used in that specific batch, compliance with GMP and all applicable EU laws and regulations as well as the positive outcome of the state control.

Biocides

Towards full implementation of the Biocidal Products Regulation in Italy (due by 31 December 2024), products that were on the market before the entering into force of the BPR, containing active substances under review in accordance with requirements provided by the new BPR, can still be manufactured and placed on the market in accordance with Presidential Decree 392/1998 and Order of the Ministry of Health of 5 February 1999 as medical-surgical devices (Presidi medico-chirurgici).

Production of medical-surgical devices can take place in sites holding a manufacturing authorisation granted by the Ministry of Health.

Production of products with active substances approved in accordance with the BPR are classified as biocides.

Manufacturing sites are subject to inspections and must have appropriate manufacturing process documentation on the quality and safety of the biocidal product.

Cosmetics

EU Regulation 1223/2009 on cosmetic products is the reference law.

The responsible person ensures compliance with obligations of the Regulation in terms of, by way of example:

• safety;
• compliance with good manufacturing practices; and
• notification to the EU Commission prior to placing the product on the market.

The Decree of the Minister of Health of 27 September 2018 sets out procedures for control of the internal market for cosmetic products, of products, manufacturers, compliance with GMPs and obligations and communication requirements operators must fulfil according to vigilance and surveillance activities, as per the Regulation on cosmetic products.

Personal Protection Equipment

Personal Protection Equipment (PPE) must comply with requirements provided for under EU Regulation 425/2016 (PPE Regulation).

The manufacturer is required to keep technical documentation of the PPE, as per Annex III of the PPE Regulation. The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the PPE with the applicable EHSR in Annex II.

Legislative Decree 17/2019 amended national laws on PPE to make them consistent with the PPE Regulation.

CBD (Cannabidiol)

The Decree of the President of the Republic 309/1990 is the reference law.

Narcotic or psychotropic substances are subject to supervision and control of the Ministry of Health. Cannabis is allowed for therapeutic purposes upon non-repeatable prescription and considering the specific pathological condition of the patient.

Food and Nutrition Supplements

EU Regulation 852/2004 requires a food operator to notify the appropriate competent authority of each establishment (ie, manufacturing site) under its control, with a view to register it. Food operators shall also ensure that the competent authority always has up-to-date information on establishments, and that the establishments are approved by the competent authority, following at least one on-site visit, when approval is required.

EU Regulation 853/2004 provides that manufacturers of food of animal origin must either register with or obtain a manufacturing authorisation from the competent authority for each establishment.

Legislative Decree 193/2007 identifies the Ministry of Health, the regions and the local health agencies as the competent authorities for application of EU Regulations 852 and 853 of 2004.

EU Regulation 625/2017 lays down detailed regulations on official controls.

EU Directive 46/2002 on food supplements (as amended by EU Regulation 418/2021) provides that national establishments manufacturing food supplements are subject to prior authorisation by the competent authority (ie, regions, autonomous provinces of Trento and Bolzano and the health agencies).

Authorisation can be suspended or withdrawn in the case of lack of the requirements listed above.

Inspections can be carried out at any time by the Ministry of Health.

Good manufacturing standards for food supplements are published in the form of recommendations by the Ministry of Health.

There are no legal obligations or any legal requirements on corporate social responsibility in Italy, which is a form of self-regulation. However, companies from different sectors have been increasingly investing resources in this field in the last few years, especially those active in sectors having or expected to have a social role and special responsibility towards society, such as pharma, healthcare, life sciences and energy companies.

Nowadays, some companies are used to disclosing their corporate social responsibility activities in their SEC or other national filings.

In terms of environmental obligations, the reference law in Italy is Legislative Decree 152/2006 as amended by Law Decree 77/2021.

Medicinal products are special waste regulated by Decree of the President of the Republic 254/2003. Sanitary waste is basically split into two macro categories of dangerous and non-dangerous sanitary waste. Depending on classification, there are different obligations for the producer of sanitary waste with regard to, for instance, management, traceability, deposit.

Law 62/2022 (the “Italian Sunshine Act”) introduced provisions on the transparency of relationships between manufacturing companies, subjects involved in the health sector (eg, HCPs) and health organisations.

Medicinal Products

Article 113 of Legislative Decree 219/2006 defines advertising of medicines.

Medicinal products with no national or European marketing authorisation cannot be advertised.

Advertising must be consistent with a summary of product characteristics and must be objective, encouraging rational use of the product, not overstating the properties of the drug and not misleading.

Advertising to the public is not allowed, except for over-the-counter (OTC) products or medicinal products that do not require a medical prescription dispensable by a pharmacist.

It is also forbidden to distribute to the public samples of medicinal products.

By way of example, advertising to the public cannot contain any elements that:

• make a doctor's consultation or surgery appear superfluous;
• are aimed exclusively or mainly at children; and
• include a recommendation from scientists, healthcare professionals or persons widely known to the public.

Advertising of medicines to the public must be authorised by the Ministry of Health, with the exception of promotional messages in newspapers or the periodical press that reproduce in full the information of the leaflet, with a possible addition of a picture or graphic representation of the primary or secondary package.

Should the Ministry of Health not provide authorisation within 45 days from application, authorisation is deemed granted.

Advertising is allowed to HCPs authorised to prescribe or dispense medicinal product, and must comply with guidelines adopted by AIFA and Regions (Guidelines of the Conference of State-Regions adopted with Regulation of 20 April 2006).

Advertising to HCPs must include a summary of product characteristics, specify the class of reimbursement, and the price and condition of reimbursement by the NHS.

Specific additional constraints and requirements are also set:

• by the Medicinal Product Code as of the distribution of medicinal products and documentation that can be shown and made available to attendees during conferences/congresses;
• by the Agreement between Government, Regions of 2 February 2017 for sponsoring of accredited educational events (Continuous Education in Medicine – ECM events); and
• by the Deontological Code of Farmindustria. 

Advertising on the web is subject to rules stated by the Medicinal Product Code integrated by the Guidelines of the Ministry of Health. The general rule is that any information related to medicinal products requiring a medical prescription must be uploaded in a restricted area dedicated to healthcare professionals with credentials.

Use of social media (eg, Facebook, YouTube, Instagram) for promotion of OTC products is allowed with no interactions with the public, a proper disclaimer and additional requirements as set forth in the Guidelines of the Ministry of Health of 2017, amended in 2018.

Medical Devices

Advertising to the public is prohibited for medical devices which may be sold under medical prescription or used with the assistance of a doctor or other healthcare professional.

Advertising to the public of medical devices different from those stated above is subject to the authorisation of the Ministry of Health, which has a 45-day term from submission of the request to approve or reject the application.

Advertising to healthcare professionals is not subject to authorisation.

It is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or patient about the device's intended purpose, safety and performance.

In relation to advertising through new means of communication (eg, internet, email, SMS), the Ministry of Health issued the following guidelines:

• Guidelines of 17 February 2010 on advertising of OTC, medical devices, in vitro medical devices, medical-surgical devices (Presidi medico-chirurgici) and veterinary medicinal products;
• Guidelines of 28 March 2013 on advertising of medical devices, in vitro medical devices and medical-surgical devices; and
• Guidelines of 20 December 2017 on advertising of medical devices, in vitro medical devices and medical-surgical devices, with a particular focus on social media (integrated in 2019 for Facebook).

Biocides

Advertisement of medical-surgical devices is subject to prior authorisation by the Ministry of Health. In general, manufacturers cannot use or distribute labels and promotional material that are not consistent with the ones approved by the Ministry of Health. The applicant must specify means of diffusion of the advertising message. If the means of diffusion is social media, the Guidelines of the Ministry of Health of 20 December 2017 (as integrated in 2019 for Facebook) apply.

Under Article 72 of EU Regulation 528/2012, any advertisement for biocidal products must include the following sentences: Use biocides safely. Always read the label and product information before use.

Any advertisement for a substance classified as hazardous shall mention hazard classes or hazard categories concerned.

Cosmetics

Advertising of cosmetic products to the public is not subject to authorisation.

However, EU Regulation 655/2013 provided common criteria for justification of claims used in relation to cosmetic products, including for claims used in advertising messages related to those products. Six principles have been established:

• legal compliance;
• truthfulness;
• evidential support;
• honesty;
• fairness; and
• informed decision-making.

The responsible person must make sure that all advertising messages comply with the six principles.

All advertising messages must comply with Legislative Decree 206/2005 (Italian Consumer Code) with reference to Articles 18–27.

Curative claims are not allowed for cosmetic products.

Personal Protection Equipment

Advertising of PPE to the public is not subject to prior authorisation.

All commercial practices and advertising messages must comply with rules set forth by Italian Consumer Code, with particular reference to Articles 18–27, and with reference to Legislative Decree 146/2007 on misleading and comparative business-to-business advertising.

Advertising is also subject on a voluntary basis to the Code of Marketing Communication Self-Regulation.

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

Advertising and presentation of food (including, for instance, shape, packaging, the manner in which they are arranged) and the information which is made available about them, cannot mislead consumers.

EU Regulation 1169/2011 deals with food information to consumers and provides more detailed provisions related to information given to the public and fair commercial communication practices. These “food information practices” are applicable to advertising as well. Food information should not be misleading, nor attribute to any food the property of preventing, treating or curing human disease. On the contrary, food information should be accurate, clear and easy to understand for the consumer.

All messages must comply with rules set by the Italian Consumer Code (in particular Articles 18–27).

Food supplements are also subject to regulation provided by Legislative Decree 169/2004 implementing EU Directive 46/2002.

In the case of products for which warnings are provided, the advertising message must contain an explicit invitation to read the warnings carefully.

Medicinal Products

Medicinal products cannot be placed on the market without authorisation from AIFA or European authorisation from EMA.

Applicants for marketing authorisation of generic products are not required to submit pre-clinical and clinical data results if it can be proven that the medicinal product is a generic medicine of a reference medicinal product (“originator”) authorised in Italy or at EU level.

Companies must maintain a positive risk-benefit balance for authorised medicinal products at all times, in compliance with pharmacovigilance obligations, including submission of periodic reports on product safety.

Medical Devices

Medical devices are currently undergoing changes to their legislative framework.

The MDR introduces new requirements and obligations on pre-market, marketing authorisation and post-marketing, such as but not limited to:

• different classes of risks and pre-marketing steps/approval processes;
• the introduction of EUDAMED; and
• planning, conducting and documenting a clinical evaluation in accordance with Article 61 of the MDR and Part A of Annex XIV of the MDR.

On February 2022, the MDCG published the “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD”. It addresses the appropriate application of transitional provisions to the so-called legacy devices. In particular, the guidance outlines the activities to be performed by notified bodies as part of the surveillance specified by Article 120(3) second subparagraph MDR.

Biocides

EU Regulation 528/2012 (BPR) concerns the making available on the market and use of biocidal products.

A marketing authorisation is required to commercialise biocides in Italy.

An applicant must submit a dossier containing all requirements of Annexes II and III for the biocide and the active substances.

Until full implementation of the BPR, in Italy products containing active substances that are under review in accordance with the BPR requirements can be placed on the market as Presidi medico-chirurgici.

Personal Protection Equipment

PPE must comply with requirements provided by EU Regulation 425/2016 (PPE Regulation). PPE must meet the Essential Health and Safety Requirements and must be CE-marked.

Manufacturers must draw up the technical documentation referred to in Annex III of the PPE Regulation and carry out or have carried out a conformity assessment procedure as per Article 19.

PPE is classified into three risk categories (Annex I):

• Category I – PPE that can be placed on the market by the manufacturer with an EU Declaration of Conformity; and
• Categories II and III – PPE that must be pre-evaluated by a Notified Body that has to issue a Certificate of Conformity, pursuant to which the manufacturer can produce a Declaration of Conformity.

Cosmetics

No marketing authorisation is required to market a cosmetic product in Italy but rather a notification requirement prior to placing the cosmetic product on the market to the Cosmetic Products Notification Portal of the EU Commission. The responsible person, as identified by EU Regulation 1223/2009, has full responsibilities over the products that are assignable either to pre-marketing/upstream or to post-marketing downstream phases of a cosmetic product's life cycle.

The responsible person is also obligated to assure compliant fulfilment of downstream or post-marketing activities such as compliance with labelling requirements, and compliance of the product claims on the labelling and advertising with rules and limits provided by law.

Post-marketing surveillance responsibilities, controls and procedures are as defined by Decree of the Ministry of Health of 27 September 2018. The Ministry of Health oversees compliance with the EU Regulation.

Said Decree requires manufacturers, within 30 days from the start of manufacturing activities at each site, to send a communication to both the Ministry of Health and the region where the site is located with at least the following information:

• name of the manufacturer;
• full address of the site;
• list of cosmetics manufactured at the site; and
• indication of the activities performed at the site (eg, packaging).

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

Surveillance of the market is ruled by EU Regulations 852/2004 and 853/2004 dictating strict requirements and rules related, respectively, to hygiene of general foodstuffs and food of animal origins. Manufacturing sites need to be communicated, registered or authorised with and by the competent authority.

EU Regulation 625/2017 provides specific rules on organisation of official controls.

In Italy, competent authorities for market surveillance and controls are the Ministry of Health, the regions and local health agencies.

EU Directive 46/2002 concerns food supplements. Commercialisation of food supplements in Italy is subject to a labelling notification procedure to the Ministry of Health at the time of first commercialisation.

The will and appetite for internationalisation of Italian companies is influenced by different but connected factors such as the size of a company, cost of raw materials, tax regimes and incentives, labour costs, etc.

Some of these factors can be considered as leading to some level of internationalisation of a company, but do not derive from a planned and robust internationalisation strategy and investment plan, as such. This is often due to lack of financial and technological resources or lack of adequate management skills and vision.

Depending on sectors, the regulatory regime might also play a role in determining or influencing internationalisation processes, although companies operating in heavily regulated sectors (eg, pharmaceuticals, medical devices) and aspiring to sell products globally cannot avoid sticking and complying with strict regulatory rules and controls.

Medicinal Products

A marketing authorisation holder (MAH) must always maintain a positive risk-benefit balance for its authorised medicinal products.

An MAH must possess adequate pharmacovigilance and a risk-management system managed by a pharmacovigilance-qualified person who is an EU resident and in possession of appropriate professional requirements.

An MAH must record all suspected adverse reactions in the EU or third countries, brought to its attention spontaneously by patients or healthcare professionals, or occurring in the context of post-marketing studies.

An MAH must transmit to EudraVigilance (the European Union Drug Regulating Authorities Pharmacovigilance system), all adverse reactions in the EU or third countries:

• within 15 days from knowledge of the event for serious suspected adverse reactions; and
• within 90 days from knowledge of the event for non-serious suspected adverse reactions.

An MAH is also required to submit periodic reports on product safety through the EMA’s PSURs repository according to the indication of the marketing authorisation (or for an MA granted before 21 July 2012):

• every six months in the first two years from authorisation;
• once per year in the following two years; and
• every three years afterwards.

CBD (Cannabidiol)

Post-marketing surveillance of suspected adverse reactions to medicinal products based on cannabidiol is co-ordinated by the Superior Institute of Health (ISS) and is carried out through the collection of reports of suspected adverse reactions associated with the administration of named galenic preparations derived from cannabis.

Healthcare professionals who observe a suspected adverse reaction must promptly notify the ISS within two working days from the reaction through the report form on the websites of the ISS, the Ministry of Health and AIFA.

Medical Devices

MDR and IVDR introduce safety and vigilance obligations similar to that for pharmaceuticals.

In accordance with the MDR, manufacturers must establish, document, implement and update a post-market surveillance system proportionate to the risk class of each device.

If a preventative or corrective action is needed, the manufacturer must implement it and inform the competent authorities and, where applicable, the notified body.

Manufacturers of Class IIa, Class IIb and Class III devices must prepare a periodic safety update report (PSUR) for each device. 

Manufacturers are also required to report to the competent authority (ie, Ministry of Health) the following:

• any serious incident involving devices made available in the EU, not later than 15 days after they become aware of the incident (ten days in the case of death or most serious life-threatening cases); and
• any field safety corrective action of devices made available in the EU before implementing the corrective action (except in cases of urgency).

Following the reporting of a serious incident, the manufacturer must investigate the serious incident and the device concerned. The manufacturer must provide a final report (Manufacturer Incident Report, MIR) to the Ministry of Health, with its findings setting out conclusions and corrective actions needed.

Field safety corrective actions must also be reported to the users of the device by means of a field safety notice (FSN).

Additional guidance on safety reporting activities and remedial actions are in the Guideline MEDDEV 2.12-1 rev 8 and the Additional Guidance Regarding the Vigilance System, and, at national level, in the Decree of the Ministry of Health of 15 November 2005.

Italian legislation on MDs, in particular Legislative Decree 46/97, is currently under review pursuant to Law 53/2021 in order to make it consistent with the MDR.

The Decree of 31 March 2022 issued by the Ministry of Health establishes the national device-vigilance network and an information system to support it.

According to the Decree of the Ministry of Health of 15 November 2005, HCPs of both public and private institutions must report an incident or missed incident to the Ministry of Health and, possibly, also to the manufacturer or authorised representative and/or distributor of the medical device with the utmost urgency.

The incident must be reported not later than:

• ten days from the event for incidents; or
• 30 days from the event for near misses.

The MIR to the Ministry of Health is due within 30 days from the reporting of the incident.

IVDR establishes, mutatis mutandis, provisions similar to the MDR. Article 11 of Legislative Decree 332/2000 provides for surveillance and reporting obligations to the Ministry of Health of any serious incident involving a device.

Personal Protection Equipment

PPE must comply with the requirements provided for under EU Regulation 425/2016.

The national legal framework has been amended to make it compatible with EU Regulation 425/2016 and with Legislative Decree 17/2019.

In Italy, post-marketing surveillance functions and obligations are performed by the Ministry of Economic Development and the Ministry of Labour.

Biocides

EU Regulation 528/2012 concerns the making available on the market and the use of biocidal products.

The Ministerial Decree of 10 October 2017 defines the responsibilities of the Ministry of Health as the national competent authority for monitoring and control activities referring to subsequent agreement of the Conference of State-Regions (signed on 6 December 2017) to identity the specific competence of regions.

An MAH must keep records of the biocidal products placed on the market for:

• at least ten years after placing on the market; or
• ten years after the date on which the MA was cancelled or expired, whichever is the earlier.

Cosmetics

EU Regulation 1223/2009 is the relevant regulation on cosmetic products.

The basic principle set forth in the Regulation is that a responsible person must be designated within the EU to place the cosmetic products on the market. The responsible person's obligation includes post-marketing surveillance activities.

The responsible person who considers that a cosmetic product placed on the market is not compliant with the EU Regulation must immediately take the corrective measures necessary to make the product compliant, withdraw it or recall it, as appropriate.

Where the cosmetic product presents a risk to health, the responsible person must immediately inform the competent authorities of the member states where the product was made available and of the member state where the product information file is readily accessible, detailing the non-compliance and the corrective measures taken.

As for serious undesirable effects, the responsible person (and distributors) must notify the competent authority of the member state (in Italy, the Ministry of Health) where the serious undesirable effect occurred.

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

If a food business operator considers that a food it has imported, produced, processed, manufactured or distributed is not compliant with food safety requirements, it shall (i) immediately initiate procedures to withdraw the food from the market where the food has left the immediate control of that initial food operator, and (ii) inform the competent authorities.

A food operator must immediately inform the competent authorities if it considers that a food it placed on the market may be injurious to human health. Operators must inform the competent authorities of the action taken to prevent risks to the final consumer.

This “traceability” principle leaves to food operators the freedom to determine how best to comply with it in order to identify the batches that are not compliant with safety requirements so to avoid massive recalls; see also Agreement of the State-Regions Conference of 28 July 2005 and 5 May 2021 on the National Guidelines for the functioning of a Rapid Alert System of Food and Feed.

EU Regulation 625/2017 provides specific rules for the organisation of controls. Legislative Decree 27/2021 harmonised national legislation to EU Regulation 625/2017, and indicated the Ministry of Health, the regions, and local health agencies as the competent authorities for controls.

EU Directive 46/2002 specifically concerns food supplements. It was implemented with Legislative Decree 169/2004, which also provides for a vigilance annual plan to be agreed by the Ministry of Health in agreement with the State-Regions Conference.

The Italian regulatory authorities are as follows.

• Medicinal products:
1. Ministry of Health;
2. Italian Drug Agency, AIFA; and
3. European Medicine Agency, EMA.

• Medical devices:
1. Ministry of Health (Directorate of Medical Devices and Pharmaceutical Services).
• Blood products:
1. Ministry of Health; and
2. Italian Drug Agency, AIFA.
• CBD:
1. Ministry of Health; and
2. Superior Institute of Health, ISS.
• Personal Protection Equipment:
1. Ministry of Economic Development; and
2. Ministry of Labour.
• Food and nutrition supplements:
1. Ministry of Health.
• Biocides:
1. Ministry of Health;
2. European Chemicals Agency, ECHA; and
3. EU Commission.
• Cosmetics:
1. Ministry of Health.

Medicinal Products

Ministry of Health

The Ministry of Health is in charge of general guidelines and vigilance of the activities of AIFA.

AIFA

AIFA oversees assessment, review, authorisation, supervision, monitoring of the development, manufacturing, price and reimbursement conditions, promotion and sale of medicinal products.

By way of example, AIFA is responsible for the following activities:

• granting national manufacturing authorisation;
• granting marketing authorisation;
• negotiation and determination of sale price and reimbursement conditions;
• inspections/audits; and
• suspension or withdrawal of the manufacturing authorisation.

EMA

The European Medicine Agency is responsible for the scientific evaluation, supervision and control of the safety of medicinal products at EU level.

It is responsible for reviewing EU-centralised marketing authorisations for the following product categories:

• biotech drugs;
• new active substances for specified diseases;
• orphan medicinal products;
• advanced therapy medicinal products; and
• optional for other substances that are (i) a significant therapeutic, scientific or technical innovation, and (ii) in the interest of public health at EU level.

Two key committees within the EMA are:

• the Committee for Medicinal Products for Human Use; and
• the Pharmacovigilance and Risk Assessment Committee.

The Commission has authority to grant, refuse, vary, suspend, withdraw, or revoke a marketing authorisation, and impose penalties for non-compliance with the obligations relevant to marketing authorisations.

Medical Devices

The Ministry of Health (Directorate of Medical Devices and Pharmaceutical Services) has supervision and surveillance powers over a medical device’s safety and conformity with applicable laws and regulations.

The Ministry can:

• order withdrawal/recall from the market;
• impose a sales ban;
• prevent placing of the device on the market or into service; and
• issue orders and corrective actions to manufacturers for ascertained non-conformity of their products with sanctions in the case of non-compliance.

The Ministry is the addressee of any communications from the manufacturer of incidents involving a medical device and any communications from healthcare institutions and healthcare professionals.

The Ministry is responsible for qualifying and authorising applicants as approved notified bodies and supervises the notified bodies and legal requirements.

The Ministry is also empowered to carry out announced/unannounced inspections and audits to sites and warehouses.

Personal Protection Equipment

The Ministry of Economic Development and the Ministry of Labour and Social Policies are responsible for surveillance of the PPE market. For instance, they:

• carry out safety evaluation of PPE if they believe there is a risk to health or safety;
• require manufacturers to provide all information and documentation to demonstrate the conformity of PPE with the PPE Regulation; and
• apply sanctions in the case of non-compliance.

Food and Nutrition Supplements

By way of example, the Ministry of Health is empowered to:

• register or authorise manufacturing sites, as applicable;
• carry out investigations and controls with local competent authorities, and inspections, usually unannounced, of establishments; and
• order the recall, withdrawal, removal and destruction of goods.

National establishments manufacturing food supplements are also subject to prior authorisation and surveillance by the competent authority as identified in Law 189/2012 (ie, the regions and local health agencies).

Cosmetics

By way of example, the Ministry of Health, as the Italian competent authority, is empowered to:

• oversee compliance with EU Regulation 1223/2009 with the collaboration of the regions and autonomous provinces;
• require the product information file of the cosmetic product from the manufacturer;
• collect the data of the activities and inspections carried out by the regions and autonomous provinces; and
• order withdrawal or recall of the cosmetic product from the market.

Biocides

The General Directorate of Medical Devices and Pharmaceutical Services of the Ministry of Health drafts and approves the Annual National Control Plan on biocides, based on data, information and results of controls and surveillance made at a local level in the territory.

The Ministry is empowered to control conformity of biocides with BPR.

The Ministry of Health is empowered to grant marketing authorisations at national level to local applicants and amend or cancel any such authorisations. As for products containing active substances under review in accordance with BPR requirements and that can be placed on the market in accordance with Presidential Decree 392/1998 as Presidi medico-chirurgici, the national application for marketing authorisation is reviewed and approved by the Ministry of Health and the National Institute of Health.

Medicinal Products

By way of example, typical product safety offences are:

• promotion and sale of a medicinal product without marketing authorisation or with a suspended or revoked marketing authorisation;
• production of medicinal products without manufacturing authorisation or with a suspended or revoked authorisation;
• promotion of the medicinal product outside approved indications; and
• production and distribution of falsified or illegal products.

Offences can represent either criminal or administrative offences, with a different regime of sanctions/penalties.

Criminal sanctions are issued against individuals, although certain criminal offences may trigger corporate criminal liability, pursuant to Legislative Decree 231/2001.

Medical Devices

By way of example, typical product safety offences are:

• lack of compliance with essential requirements and non-conformity with and of the CE marking;
• placing on the market or putting into service a medical device without a CE mark or certification of conformity; and
• lack of reporting of incidents to the Ministry of Health by healthcare organisations and/or healthcare professionals.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Personal Protection Equipment

By way of example, typical product safety offences are:

• manufacturing or placing on the market by the manufacturer or importer PPE not compliant with essential health and safety requirements;
• placing of PPE onto the market without the EU declaration of conformity; and
• putting unclear, misleading or confusing marks, signs or other inscriptions on the PPE.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Cosmetics

By way of example, typical product safety offences are:

• violations of safety requirements and obligations by manufacturing, possessing or placing onto the market cosmetics dangerous to consumers’ health;
• lack of compliance by the responsible person with his or her market surveillance duties and lack of implementation of remedial actions; and
• lack of compliance with GMPs.

Legislative Decree 204/2015 established the regulatory regime applicable to the provisions of EU Regulation 1223/2009.

Offences can represent either criminal or administrative offences, with a different regime of sanctions/penalties.

Biocides

By way of example, typical product safety offences are:

• placing onto the market or use of a biocide without authorisation in accordance with BPR;
• lack of compliance of the classification, packaging and labelling of the biocide with the requirements of the summary of biocidal product characteristics; and
• violation of the notification obligations of unexpected or adverse effects.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Criminal sanctions are issued against individuals although certain criminal offences may trigger corporate criminal liability pursuant to Legislative Decree 231/2001.

A scheme of legislative decree for adoption of the regulatory regime related to the application of BPR is currently under evaluation and discussion in the Italian Parliament, pursuant to Law 117/2019. Criminal and administrative sanctions for violations of the biocide requirements are currently set forth in Legislative Decree 174/2000.

Food and Nutrition Supplements

By way of example, typical product safety offences are:

• violation of obligations of withdrawal from the market of food not compliant with food safety requirements;
• lack of or refusal to collaborate and provide data and information required by the competent authority; and
• violation of the obligation to inform those consumers who have acquired the product of any withdrawal/recall of food products.

Legislative Decree 190/2006 established the regulatory regime applicable to EU Regulation 178/2002. Offences can represent either criminal or administrative offences.

Typical product safety offences for food supplements are, for instance:

• manufacturing and packaging of food supplements without manufacturing authorisation;
• placing on the market food supplements without prior labelling notification to the authority; and
• violations of the obligations related to labelling, presentation and advertising of supplements.

Legislative Decree 169/2004 established the regulatory regime applicable to the provisions of EU Directive 46/2002. Offences can represent either criminal or administrative offences, with a different regime of sanctions/penalties.

EU Directive 374/85 on General Product Liability was implemented in Italy with Presidential Decree 224/1988, subsequently incorporated into Legislative Decree 206/2005 (the Consumer Code).

The Consumer Code provides a strict liability that can be claimed by consumers for damages caused by a defective product. This liability is alternative to contractual and tortious liabilities governed by the Civil Code.

Article 2043 of the Italian Civil Code sets the tortious liability to be based on the duty of care concept.

Article 2050 of the Italian Civil Code provides for strict liability (ie, presumption of liability) for those who exercise a per se dangerous activity.

Under the Consumer Code, the manufacturer is the first subject liable for damages caused by a defective product.

The distributor may also, residually, be held liable in cases where the manufacturer is not identified.

The manufacturer can escape liability if it is able to demonstrate that the defect, the damage or the casual link does not exist.

There is no specific Italian law concerning liability of products characterised by technological advancements such as IA. Therefore, a case-by-case assessment has to be made based on the Italian Civil Code and Consumer Code rules, as well as the Criminal Code, if applicable.

Jurisdiction over disputes related to personal rights between private parties or private/public parties lies with the Ordinary Civil Courts:

• lower courts (Giudice di pace) for minor and low value claims;
• civil tribunals for first instance;
• Courts of Appeal for second instance; and
• Supreme Court as third and last instance.

Within the ordinary civil courts there are specialised sections, the tribunals of enterprises specialised in disputes over specific business matters and intellectual property rights.

Administrative courts have jurisdiction over disputes around the legitimate interests of individuals or people vis-à-vis the acts, orders and determinations of public administrations:

• Regional Administrative Tribunals (first instance administrative courts); and
• Council of State (Consiglio di Stato, the administrative Court of Appeal located in Rome).

The Italian Constitutional Court has jurisdiction over, by way of example, cases of constitutional legitimacy of laws, acts having force of law of the state and the regions.

The judge orders the losing party to refund the legal costs in favour of the counterparty and quantifies them usually on a fixed basis, based on the amounts provided for by Ministry Decree 55/2014.

In doing so, usually the judge excludes costs deemed excessive or unjustified.

However, the judge may also decide to compensate, fully or partially, the costs between the parties.

Acts, decisions or determinations of public administrations affecting legitimate interests of individuals can be challenged before the administrative courts. The regional administrative tribunal of Lazio (TAR Lazio) has jurisdiction over acts and decisions of the AIFA and of the Ministry of Health. Decisions of administrative tribunals can be appealed before the Council of State (Consiglio di Stato). 

There are many examples where the determinations/decisions of the AIFA have been challenged in court by pharmaceutical companies (eg, legal actions versus the pay-back, the legal mechanism requiring all pharmaceutical companies to pay back to regions the over-expenditure of reimbursed medicinal products vis-à-vis the budget allocated to them). Other contentious areas are price negotiation and reimbursement conditions of medicinal products.

Class actions are litigations where a large group of plaintiffs is considered a class and is represented by an individual "class representative". The class representative stands in court for the class and all members are treated as one plaintiff.

In May 2021, a new regulation for class action was introduced. It is now incorporated into the Italian Code of Civil Procedure and abrogated relevant measures on class action that were included into Legislative Decree 206/2005 (Italian Consumer Code). The new regulation is applicable to the illicit conducts committed after its entry into force; for conducts that occurred before (ie, prior to 18 May 2021), the old regulation of the Consumer Code will continue to apply.

Pursuant to Italian legislation, individual homogeneous rights can be protected by means of a class action. Entities entitled to initiate a class action to seek compensation for damages or restitution are:

• each individual/consumer member of the class; and
• consumers’ associations and/or not-for-profit organisations having as statutory objective the protections of rights violated, provided that the class action is to protect “individual homogeneous rights” and that such associations and organisations are registered in a public list held by the Ministry of Justice.

The proceeding on the merit is subject to a preliminary filter of the admissibility of the demand.

Unlike the USA, where an “opt-out” mechanism is adopted, Italian legislation provides for an “opt-in” mechanism to join a class action. If the action is considered admissible by order of the judge, a term between 60 and 150 days from the date of the publication of the order is granted to allow other members of the class to “opt-in”.

ADR mechanisms available are:

• amicable settlement;
• judicial or extra-judicial conciliation;
• arbitration; and
• mediation with the help of an independent and impartial person.

Product liability cases might also entail a criminal liability, especially in cases where the harmful event is caused by lack of quality or compliance with safety requirements, either intentionally or due to negligence. In particular, for categories of goods that are strictly related to health and aimed at safeguarding the health and safety of the users and patients, a civil liability or administrative dispute can flow into a criminal investigation.   

The Next Generation EU Plan triggered the adoption by the Italian government of the National Recovery and Resilience Plan (PNRR). Among many areas of planned interventions, the PNRR provides for investments to modernise the technological base of Italian hospitals. The investment involves:

• the digital modernisation of the existing technologies whose obsolescence is five years beyond their normal life cycle through the purchase of 3,133 new items of high-tech equipment (eg, CT scanners); and
• interventions aimed at enhancing levels of digitalisation of hospitals.

This modernisation and digitalisation should have a positive impact on the environment, as well as on the health and safety of patients.

On 25 November 2020, the EU Commission adopted its Pharmaceutical Strategy for Europe. As part of this, the EU Commission is working on specific matters, such as:

• revision of EU general legislation on medicinal products; and
• a legislative proposal on a European Health Data Space.

Moreover, Regulation (EU) 2021/2282 on health technology assessment was adopted on 15 December 2021.

Medical devices are in a transition phase, with gradual implementation of the MDR and of IVDR. Italian legislation on medical devices is currently under review to make it consistent with the MDR.

Several legislative initiatives are currently being set up towards the implementation of the objectives of the PNRR.

COVID-19 had a huge impact in terms of special legislation swiftly promulgated to face the state of emergency and to meet the increasing demand for intensive care medical devices, such as ventilators, intensive care monitoring devices, surgical masks and personal protection equipment.

Moreover, the COVID-19 emergency period sped up telemedicine services as well as the adoption of relevant regulation on e-prescriptions.