The EU Commission proposal to extend the MDR transition timelines was approved by the European Parliament in February 2023 and is anticipated to come into effect mid-March once it receives final approval from the EU Council and is published in the Official Journal of the European Union.
The proposal provides additional time for devices transitioning to the MDR by extending the transition timelines specified in Article 120 of the MDR to either the end of 2027 or 2028 based on the classification of the devices. At the same time, for devices transitioning to MDR, their Directive Certificates will be recognised as being valid even beyond their expiry dates until the end of 2027 or 2028 to enable manufacturers to place such devices on the market based on their Directive Certificates. However, the additional time comes with conditions attached that the manufacturer must fulfil.
Key takeaways and learning objectives
A clear understanding of the new amending Regulation and its impact, especially in relation to:
- The new transition timelines, which devices benefit from them and under what conditions
- Conditions under which devices covered by expired MDD/AIMDD certificates can benefit from the longer transition timelines
- Abolishment of the sell-off provisions in the MDR and its impact
- Transfer of appropriate surveillance from your Directive Notified Body to the MDR Notified Body (in cases where these are different)
- Notified Body implementation of the new amending Regulation and potential timelines
Speaker - Jayanth Katta, Regulatory Director & Head of Medical Devices Notified Body
Speaker - Suzanne Halliday, VP Regulatory