On 9 July 2024, Regulation (EU) 2024/1860 amending the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) was published in the Official Journal of the European Union. In particular, the new Regulation amended the provisions regarding the mandatory use of the European Medical Device Database (EUDAMED) for devices compliant with the MDR and IVDR and for legacy devices, providing for a phased implementation of the modules as they are verified and declared functional.

In a statement published on 18 June 2024, the European Medicines Agency (EMA) called on marketing authorization holders (MAHs) to adopt a Medicines Shortage Prevention Plan to reduce and prevent possible shortages and critical issues. The purpose of such a Plan is to collect information on the product, European and international marketing, supply chain vulnerabilities, measures to prevent shortages and, where appropriate, to reduce their impact on public health, and must contain appropriate measures to address shortages and mitigate their impact on patients.

Following the public hearing held on 22 May 2024, on 22 July 2024, the Italian Constitutional Court issued two judgments (judgment No. 139/2024 and judgment No. 140/2024) to decide the various appeals concerning the legitimacy of medical device payback regulation, i.e., the system under which medical device companies are required to contribute to the coverage of the NHS deficit in the years 2015-2018. 

On 10 June 2024, the Member State Coordination Group on Health Technology Assessment adopted new HTA guidance on outcomes of joint clinical assessments and reporting requirements. In particular, the guidance on outcomes for clinical assessments aims at supporting both Member States’ authorities in defining the scope of such assessments and those responsible for such assessments in reporting all the elements needed by Member States to properly conduct clinical value-added analysis of health technologies at the national level.

On 3 May 2024, the European Medicines Agency (EMA) published new Q&As for applicants, marketing authorization holders of medicinal products, and notified bodies on the implementation of the EU Regulations on medical devices and in vitro diagnostic medical devices (i.e., EU Regulations 2017/745 and 2017/746). The new Q&As are based on the experience gained from the application of the regulations and the specific cases encountered so far, and aim at providing practical considerations on the relevant implementation, with particular reference to those products that consist of a combination of medicinal products with medical devices.

The EU has approved the new Regulation on Substances of Human Origin (SoHO) aimed at improving the safety and quality of blood, tissues and cells used in health care and facilitating the circulation of these substances within the EU. The new regulation broadens the scope of SoHO to human breast milk and intestinal microbiota and covers a variety of activities, ranging from registration and testing of donors, collection and processing to human application and clinical outcome monitoring of substances of human origin.

New transparency rules related to the Clinical Trials Information System (CTIS), adopted by the Management Board of the European Medicines Agency (EMA) in October 2023, became applicable on 18 June 2024. These rules aim at striking a balance between transparency and the protection of commercially confidential information for the benefit of patients, who will have early access to key clinical trial information, of healthcare professionals, who will enjoy simplification in accessing to trial information and enrollment, and of trial sponsors, who will interact with a more user-friendly system.

On 22 May 2024, the Italian Constitutional Court held a public hearing to discuss the issue of the legitimacy of medical device payback regulation, as raised by the Lazio Regional Administrative Court, for conflicting with Articles 3, 23, 41, and 117 of the Constitution.

The European Medicines Agency’s Medicines Shortages Steering Group recently developed a list of recommendations in hopes of increasing the availability of critical medicines flagged for supply chain vulnerabilities or risks.

The European Parliament voted in favor of a digital EU Health Data Space for electronic health records. Despite various policy concerns about data privacy, increasingly urgent health demands render efficient access to personal electronic health data necessary across all Member States.