Regulation Transitional Changes & Annex XVI Update

Date15th December 2022

Following the EPSCO meeting on 09 December 2022, BSI is pleased that the European Commission has indicated that they intend to bring forward legislation to extend the date by which medical devices must fully comply with the requirements of the EU Medical Device Regulation (MDR). This will provide much needed time for all involved in implementing the MDR to ensure that safe, high quality medical devices remain available for patients in the EU.

The full draft proposal to amend EU 2017/745 and EU 2017/746 is here:

MDR Timelines

The changes may allow all classes of medical device under 90/385/EEC and 93/42/EEC to remain on the market longer than the existing end of transition 26 May 2024.

Manufacturers may only be able to benefit from the extra time if particular conditions are met.  The draft conditions indicate that manufacturers must continue to make progress towards adapting their QMS and Technical Documentation to meet the MDR.

We may see updated draft proposals before the end of 2022 or early 2023.  As such, BSI is preparing to be able to respond as soon as a final position is agreed. We will be communicating further as the situation becomes clearer with a process that BSI will be implementing to manage the certification requirements.

MDR & IVDR “Sell Off” Provision

The latest proposal does not amend the IVDR ends of transition previously amended in January 2022.

The draft currently under discussion does consider deleting MDR Article 120 Clause 4 and IVDR Article 110 Clause 4, which may extend the ability to make devices available or put devices into service post the end of the transition dates.

Annex XVI Transitional Agreements  

It is also important to note that the Implementing legislation that reclassifies active devices listed in Annex XVI and the Common Specification that has an Annex for each of the six groups of product without a medical purpose, were published earlier in December 2022.

(EU) 2022/2346 – Common Specification – Annex XVI
(EU) 2022/2347 – Reclassification of Active Products – Annex XVI

BSI is fully designated and accepting selected applications for certain devices listed in Annex XVI.

Who can I contact for further information?

If you have questions or concerns, please don’t hesitate to contact your BSI scheme manager or local business development manager who can provide further information.  

Yours sincerely,

Graeme Tunbridge                     
SVP Global Regulatory and Quality            
Medical Devices