The European Commission continues to refine and expand regulatory frameworks for medical devices and in vitro diagnostics (IVDs) to enhance compliance and patient safety. Recent developments include extended transition periods for IVDs, new harmonized sterilization standards, and updated guidance on clinical studies, vigilance, and EUDAMED implementation. Manufacturers must stay informed about evolving language requirements, safety reporting obligations, and the classification of medical devices versus medicinal products. The latest guidance documents also address legacy devices, reprocessing of single-use devices, and the validity of clinical studies for joint clinical assessments. Below is a summary of the most recent regulatory updates affecting the EU medical device industry.
| Date | Summary | Link |
|---|---|---|
| 23 January, 2024 | Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply Despite progress, the transition to new EU medical device rules has been slow. In 2023, the Commission proposed extending timelines for in vitro diagnostics, accelerating EUDAMED’s rollout, and mandating manufacturers to report supply disruptions to safeguard patient care. | Click here |
| 20 March, 2024 | Overview of language requirements for manufacturers of medical devices Regulation (EU) 2017/745 (MDR) lets Member States decide the language needed for medical device information. They are encouraged to allow other languages, like English, for professional-use devices if it does not affect safety. | Click here |
| 14 March, 2024 | European Commission adopts harmonized standards for medical device sterilization The European Commission has adopted implementing decisions on harmonized standards for sterilized medical devices. These decisions incorporate new sterilization standards into existing annexes for in vitro diagnostics and medical devices, ensuring compliance with EU regulations. | Click here |
| 15 April, 2024 | Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) must comply with Regulation (EU) 2017/746 (IVDR). Sponsors are required to promptly report serious adverse events and device deficiencies to all Member States where the study is conducted. | Click here |
| 10 April, 2024 | A Study and dashboard on reprocessing and reuse of single-use-devices in the EU The study, conducted over 14 months by a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG) in collaboration with Civic Consulting, S&P Global, and Areté, aimed to assess how the provisions of the Medical Device Regulation (MDR) have been applied across European countries and their operational effectiveness. | Click here |
| 27 May, 2024 | 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 The guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3e) MDR. To clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially regarding their quality management system. | Click here |
| 19 September, 2024 | Guidance on the validity of clinical studies for joint clinical assessments The European Commission has published guidance documents to support the implementation of the Health Technology Assessment Regulation (HTAR), including those related to JCAs. | Click here |
| 29 October, 2024 | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices The document explains the important differences between Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC on medicinal products for human use (MPD). Understanding these differences is key to properly applying and enforcing these laws. | Click here |
| 16 October, 2024 | Application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC Regulation (EU) 2023/607 has extended the transitional period for Regulation (EU) 2017/745 (MDR) from May 26, 2024, to December 31, 2027, or December 31, 2028, depending on the device’s risk class and certain conditions. | Click here |
| 21 November, 2024 | Gradual roll out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 The document provides a Q&A overview regarding the implementation of the gradual roll-out of Eudamed, as outlined in Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). | Click here |
| 11 November, 2024 | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 The document clarifies key terms from Reporting of serious incidents and field safety corrective actions of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) on medical devices and in vitro diagnostic devices. It aims to ensure a shared understanding of these terms for the effective implementation of vigilance requirements under both regulations. | Click here |
| 02 December, 2024 | Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED Sponsors must submit a clinical investigation report and summary via EUDAMED within one year, or three months if terminated early, with documents becoming public once the device is registered or after a year. Until EUDAMED is fully functional, national procedures and the CIRCABC directory should be used for submission and publication | Click here |
