Brussels, 6.1.2023
COM(2023) 10 final
2023/0005 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
In summary:
1. Remember that at the moment it is only a proposal (but it comes from the EU commission)
For legacy device
2. 31 December 2028, for class IIb devices other than those covered by point (a), for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.
3. 31 December 2027, for class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
4. class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026
5. Removed the sell-off date