On 15 March 2023 (Regulation (EU) 2023/607), the EU extended both the transition period for the EU Medical Device Regulations (EU MDR) and the validity of CE mark certificates. The new arrangements give manufacturers more time than previously anticipated to get their medical devices certified and they recognise the capacity challenges faced by notified bodies.
Higher-risk devices now have until 31 December 2027 to ensure that they comply with EU MDR requirements and medium to lower-risk devices until 31 December 2028 to do the same (both subject to particular conditions).
Certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC from 25 May 2017, which were still valid on 26 May 2021, have also had their validity extended to the end of the relevant transition periods (31 December 2027 or 31 December 2028 contingent on device class). This extension applies to certificates that expired before 20 March 2023, subject to meeting one of the conditions set out in the EU MDR amendments, and certificates due to expire after 19 March 2023 (so that they are now due to expire at the close of the relevant transition period).
These changes to the EU MDR will of course apply across the EU. However, on 28 March, the UK’s MHRA has confirmed that, albeit post-Brexit:
– Extensions automatically apply in Northern Ireland.
– Certificates that have been extended will also be identified as valid for placing CE-marked devices on the British market.
The extension is welcome news to medical devices players operating across the region, and the UK’s MHRA confirmation of clarity is particularly helpful to companies who have been faced with the dual challenge of MDR readiness and Brexit uncertainty.
MHRA also extends MORE deadline
Last week the MHRA made a further practical decision to extend the deadline for companies to transition to the new MORE portal from 30 April to 31 August 2023. The Manufacturer’s On-line Reporting Environment (MORE) is the MHRA’s portal for companies to report adverse incidents relating to medical devices in the UK. This reprieve is welcomed by the Association of British Healthcare Industries (ABHI), which had liaised with its members and MedTech Europe to provide feedback to the MHRA. The ABHI also notes that the former legacy MORE portal will be closed as planned on 30 April and that if any reports will be needed for local use, they will have to be downloaded before this cut off.
For further information please contact Jaspreet Takhar, Elina Angeloudi or Julia Gillert