23/02/2023
Amended Transition Timelines of Regulations (EU) 2017/745
MDR 2017/745 Transition Timeline extension has been approved.
• 31 December 2027, for class III devices and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
• 31 December 2028, for class IIb devices other than those covered by point (a), class IIa devices, and class I devices placed on the market in sterile condition or having a measuring function.
However, it is critical to note here that the devices for which the certificate has already expired before the publication of this amended regulation can only benefit from this extension provided they have already signed an agreement with notified body before the date of expiry of the certificate.
The devices for which notified body assessment were not required under the earlier directive 93/42/EEC. For which the declaration of conformity was drawn up earlier to 26 May 2021 and has now been up and classified into a higher classification requiring notified body review as per EU MDR 2017/745 can be continued to be placed in the EU market or put into service till 31 December 2028.
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