Life Sciences News in Italy: April 2026

Regulatory

EC updates Manual on borderline and classification for medical devices and IVDs

On 22 April 2026, the European Commission (EC) published Version 5 of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Although not legally binding, the Manual serves as a key reference for the consistent qualification and classification of borderline products. Version 5 introduces additional product rulings and worked examples covering devices intended to administer a medicinal product, software and digital health products, and edge cases at the boundary with medicinal products and cosmetics.

MDCG updates Guidance on classification of medical devices

On 20 April 2026, the Medical Device Coordination Group (MDCG) updated its guidance on classification of medical devices. The document introduces terminological clarifications, structural alignment with Regulation (EU) 2017/745 (MDR), and additional explanatory content to support the consistent application of the rules across the EU. The revision also adds new examples covering devices with multiple intended purposes, combination products and devices intended for both professional and home-care use, and provides expanded indications on the classification of medical device software (MDSW).

EC updates Q&A on Article 10a MDR/IVDR on supply interruption and discontinuation

On 1 April 2026, the European Commission (EC) updated its Q&A on the implementation of the MDR Article 10a obligation in case of interruption or discontinuation of supply of certain devices. The article requires manufacturers to notify the relevant competent authority and the economic operators, health institutions and healthcare professionals to whom they directly supply the device of any anticipated supply interruption or discontinuation that could result in serious harm or risk to patients or public health, as a rule at least six months in advance. The revised Q&A expands and clarifies the assessment criteria – notably the indicators to be considered in evaluating the risk of serious harm – while the new Decision Tree provides a structured framework to determine whether a situation triggers the notification obligation.

EC publishes evaluation of the EU tobacco control framework

On 2 April 2026, the European Commission (EC) published its evaluation of the EU tobacco control framework, assessing the effectiveness, efficiency and relevance of the Tobacco Products Directive (Directive 2014/40/EU) and the Tobacco Advertising Directive (Directive 2003/33/EC). The findings show that EU rules have contributed to a significant decline in smoking and tobacco-related deaths – with smoking rates falling from 28% in 2012 to 24% of the population – while also identifying shortfalls linked to the rapid emergence of novel tobacco and nicotine products (e-cigarettes, heated tobacco products and nicotine pouches) and to the evolving and often covert nature of digital promotion. On this basis, the EC will carry out an impact assessment and continue the consultation process with a view to proposing a revision of the legislative framework on tobacco control in 2026.

SCCS adopts final scientific opinion on CBD used in cosmetic products

On 24 April 2026, the European Commission (EC) published the final scientific opinion of the Scientific Committee on Consumer Safety (SCCS) on Cannabidiol (CBD) used in cosmetic products (SCCS/1685/25), adopted on 26 March 2026 following the public consultation on the preliminary version of 30 October 2025. Based on the available data, the SCCS considers CBD safe at concentrations up to 0.19% in dermal and oral cosmetic products – whether separately or in combination – and considers the presence of THC impurities as safe at concentrations up to 0.00025%; the assessment doesn’t cover cosmetic products that may lead to exposure of the end-user’s lungs by inhalation. While the SCCS opinion isn’t itself binding, its conclusions may inform a subsequent amendment by the EC of the relevant Annexes to Regulation (EC) No 1223/2009 on cosmetic products.

AIFA introduces new operational procedures for the Sunset Clause

On 28 April 2026, the Italian Medicines Agency (AIFA) published a notice setting out the new operational procedures for the Sunset Clause, following the entry into force of the new AIFA Regulation on the functioning and personnel of the Agency (Italian Official Gazette – General Series No. 220 of 22 September 2025). As of 1 January 2026, competence over the Sunset Clause has been transferred to the Post-Authorisation Procedures Office (Ufficio Procedure Post Autorizzazione or UPPA). And requests for exemption from, or exclusion of, the lapse of the marketing authorisation must be submitted exclusively by certified email (PEC) to protocollo@pec.aifa.gov.it, at least 30 days before the anticipated lapse date. AIFA has also released an updated version (rev. UPPA – April 2026) of its guideline “Sunset Clause: lapse of an MA and possible exemptions/exclusions.”

 

WCC/Compliance

Sanctioning provisions for the protection of Italian food products: New criminal offences introduced

On 15 April 2026, the Italian Chamber of Deputies approved Bill No. 1519 on the protection of Italian food products, which reforms the legal framework on offences affecting the public economy, industry, trade and the agri-food sector.

Bill No. 1519 introduces newly dedicated offences against the agri-food patrimony, and amends Article 25-bis.1 of Legislative Decree No. 231/2001, expanding the scope of corporate criminal liability with new predicate offences. The following offences have been introduced:

• “Food-related fraud” (Art. 517-sexies of the Italian Criminal Code): covers the placing on the market of non-genuine or materially different food products with intent to mislead for profit, including through digital channels.
• “Trade in food products with misleading signs” (Art. 517-septies of the Italian Criminal Code): targets the use of false or deceptive indications (including figurative or digital ones) concerning origin, provenance, quality or quantity.

Overall, the reform marks a significant development for operators in the agri-food sector, who are encouraged to assess the potential impact of the new offences on their activities, and to ensure that their compliance programs are appropriately aligned with these emerging risk areas.

Assonime publishes practical guidance on whistleblowing systems

On 20 April 2026, Assonime published the “Operational Vademecum on Whistleblowing in light of the recent Italian Anti-Corruption Authority Guidelines” (Vademecum). The Vademecum is intended to provide companies with practical support in the implementation of whistleblowing reporting systems, by offering a structured overview of the main compliance requirements, also taking into account the most common practical issues encountered. The Vademecum includes dedicated Q&A providing practical guidance on specific application aspects, and addresses the key features of whistleblowing systems, including reporting channels, the role and responsibilities of the whistleblowing manager, and the integration of such systems within compliance programs pursuant to Legislative Decree No. 231/2001 and their implementation within groups of companies. The Vademecum is a useful practical tool for companies seeking to enhance the effectiveness of their whistleblowing systems and to ensure alignment with the latest regulatory and interpretative developments.

Environmental crimes: New Italian Legislative Decree implementing Directive (EU) 2024/1203

On 21 April 2026, the Italian Council of Ministers approved the Legislative Decree implementing Directive (EU) 2024/1203 “on the protection of the environment through criminal law and replacing Directives 2008/99/EC and 2009/123/EC.” The measure strengthens the framework of environmental offences by amending the Italian Criminal Code and Legislative Decree No. 231/2001, governing corporate criminal liability. The main new or updated offences include:

• “Trade in polluting products” (Art. 452-bis.1 of the Italian Criminal Code) concerning the unlawful circulation of products causing significant environmental deterioration;
• “Production and trade ozone-depleting substances” (Art. 4 of the implementing Legislative Decree) targeting unlawful production, use and circulation of such substances and related products;
• “Production and trade of greenhouse gases” (Art. 5 of the implementing Legislative Decree) covering unlawful production, import/export and use of such gases and related equipment;

Overall, the implementing Legislative Decree significantly strengthens the criminal law framework for the protection of the environment, while expanding the scope of corporate liability under Legislative Decree No. 231/2001. Companies operating in potentially affected sectors are encouraged to consider the implications of the new provisions and ensure that their compliance programs adequately reflect the evolving regulatory landscape and related risk areas.

 

Data, Privacy and Cybersecurity

EDPB publishes Guidelines on scientific research

On 15 April 2026, the European Data Protection Board (EDPB) adopted long-awaited Guidelines 1/2026 on the processing of personal data for scientific research purposes. These Guidelines provide welcome clarification on a number of key issues, including the notion of “scientific research,” the practical application of the GDPR’s presumption of compatibility for further processing, and the continuing role of consent in the research context. For life sciences organisations in particular, the Guidelines are an important step towards greater legal certainty. At the same time, however, they also confirm the ongoing limitations applicable to secondary uses of personal data and the need for careful, case-by-case governance and assessment of research activities. Further information on this topic is available here.

Italian DPA strengthens former employees’ right of access to corporate emails

On 15 April 2026, the Italian Data Protection Authority (Italian DPA) published a decision upholding a complaint filed by a former employee who had requested access to emails contained in his corporate email account, and to documents stored on his work computer. In response to the request, the company had accessed the former employee’s mailbox and, after reviewing its contents, disclosed only the emails considered to be “strictly personal,” excluding communications related to work activities. According to the Italian DPA, the right of access applies to all personal data relating to the individual, including communications exchanged through an individualized corporate email account. As a result, it’s not lawful for the employer to pre-screen the content of the mailbox and selectively disclose only certain communications, nor to restrict or redact information based on a distinction between “personal” and “professional” content.

ACN issues new NIS2 Guidance on service categorisation and cybersecurity obligations

On 24 April 2026, the Italian National Cybersecurity Agency (ACN) published Resolution No. 155238 of 20 April 2026, setting out the process, criteria and methodology for the classification and categorisation of activities and services under Article 30 of Legislative Decree No. 138/2024, which implemented the NIS2 Directive into Italian law. The purpose of the categorisation process is to group activities and services according to their level of criticality and relevance, enabling the identification of the IT systems and network infrastructures requiring more targeted and stringent risk mitigation measures. The results of this harmonised impact assessment process must be submitted to the competent NIS authority through the ACN platform between 1 May and 30 June 2026. As is well known, the NIS2 regime applies to entities operating in the healthcare sector, including manufacturers of medical devices and manufacturers of basic pharmaceutical products and pharmaceutical preparations.

 

Antitrust

Italian Competition Authority publishes its annual report for 2025

On 14 April 2026, the Italian Competition Authority (ICA) published its 2025 Annual Report, documenting its enforcement activity in both antitrust and consumer protection law in 2025, including in the pharma and parapharmaceutical industry. The report highlights the ICA’s interventions aimed at ensuring fair markets, promoting the green transition and strengthening consumer protection.

EC updates EU competition rules for technology licensing agreements

On 16 April 2026, the European Commission (EC) adopted the revised Technology Transfer Block Exemption Regulation and Guidelines on the application of Article 101 of the TFEU to technology transfer agreements. Technology transfer agreements allow firms to license their technology rights (including patents) to others. The revisions introduce guidelines on licensing negotiation groups and clarify key concepts including “active” and “passive” sales and “potential competitor.” The new rules will enter into force on 1 May 2026.