December 8, 2022
By Annette van Raamsdonk
The European Commission plans to propose amendments to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) as concerns increase about disruptions to device supplies.
Member States, members of the European Parliament and industry stakeholders have been expressing their concerns over the past several months that severe challenges related to the implementation of the MDR threaten the continued availability of medical devices needed for healthcare systems and patients in the EU; these challenges may furthermore jeopardize access to innovative medical devices in Europe.
During a December 2022 meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), the Commission committed to establish actions to be taken to address the foreseeable shortage of medical devices in the EU caused by the challenges related to the implementation of the MDR.
Key MDR and IVDR amendments under consideration
In their Proposal No. 15520/22, European Commissioners laid out amendments to the Regulations including:
- Extending transition periods in Article 120(3) MDR based on device risk classifications, with new deadlines of 2027 for Class III and Class IIb higher-risk devices and 2028 for Class IIa and Class I lower-risk devices that require conformity assessments from Notified Bodies.
- Extending validity of CE certificates issued under the erstwhile Medical Devices Directive (MDD) 93/42/EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC if necessary for legal or third-country market access purposes.
- Applying extensions only to devices with acceptable health and risk profiles; that have not undergone any significant changes in terms of design or intended use; and whose certification processes to MDR requirements have already been initiated by manufacturers.
- Removing the "sell off" provision in Articke 120(4) MDR and Article 110(4) IVDR.
- Focusing on "what is absolutely necessary at this moment in time" to support timely adoption of legislative amendments to the Regulations.
- Addressing structural issues such as how niche devices are overseen over the longer term.
Emergo by UL consultants in Europe will track the situation and report on further details as they become available.
Annette van Raamsdonk is Lead Quality & Regulatory Affairs Consultant at Emergo by UL in The Netherlands.