Following the amendment of the EU Medical Device Regulation (EU MDR) earlier this year to extend the transitional periods for applicable devices certified under the EU Medical Device Directive (MDD) we continue to be made aware that a number of suppliers, particularly those outside of the UK and EU, are either unaware of the extensions or are not taking the steps necessary to benefit from them. The main features of the amendment are:
- Extension of the transitional period for higher-risk devices (class III and certain class IIb implantables) to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with Notified Bodies).
- Extension of the transitional period for medium and lower-risk devices (other lass IIb devices, class IIa, class Im, Is and Ir devices) to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with Notified Bodies).
- Extension of the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were valid on 26 May 2021. Subject to meeting specific conditions, this extension also applies to those certificates that expired before the amendments took effect.
- Removal of the “sell-off” period in order to allow devices certified under the old Directives and that had already been placed on the market to continue to be made available beyond May 2025.
While the extended transition periods are significant, potentially allowing applicable devices certified under the EU MDD to continue to be placed on the EU market until as late as December 2030 depending on classification, there are steps that manufacturers need to take in order to meet the eligibility criteria.
An EU Commission flowchart to assist manufacturers in this process can be found below, along with a Q&A document on the implementation of the transitional arrangements and a fact sheet for non-EU countries. In particular, attention is drawn to the following deadlines:
- 26 May 2024 – deadline to lodge an application for EU MDR conformity assessment & have an EU MDR QMS in place.
- 26 September 2024 – deadline to have a written agreement with a Notified Body & transfer appropriate surveillance to an EU MDR Notified Body (where applicable).
We would encourage BDIA members working with suppliers in relation to EU MDD devices to circulate these deadlines and documents to raise awareness and to ensure that manufacturers can benefit from applicable extensions.
