Episode description
#MedTechVoices 🗣️ continues in 2023 with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares additional thoughts on the EU MDR postponement.
Here are some key takeaways from today's MDCG proposal to amend the transition timelines for medical devices and IVDs:
- The new transition timeline for high risk medical devices (i.e. class III and IIb implantables) is now 31 December 2027
- For medium and lower risk devices, it's 31 December 2028
- For class III custom made devices it's 26 May 2026
In order to benefit from this extension, manufacturers cannot make any significant changes to the device and must have an MDR-complaint QMS by 26 May 2024. An application must be made to a notified body by 26 May 2024 and be accepted by the notified body by 26 September 2024. The benefit-risk profile of the device must also remain unchanged. No certificate expiration date updates by the notified body will be required and periodic surveillance activities by notified bodies will continue.
This timeline extension is to allow safe medical devices to stay on the market. Also, the removal of the sell-off date is to ensure warehouses in the EU are adequately stocked.
The expectation is that your MDR-preparedness is well underway. This proposal by the MDCG is expected to be voted on by the European Parliament very soon.
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