EC: Updated Q&A on MDR and IVDR

The European Commission updated the Q&A document on the new transitional provisions for certain medical devices and in vitro medical devices with five additional questions on 18 July 2023.

The Q&A was published in last March (we reported), refers to Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The regulation sets out the new transitional provisions for certain medical devices and in vitro diagnostic medical devices.

The following five questions were added to the Q&A:

6.1         Does a national derogation granted in accordance with Article 59 MDR, or the application of Article 97 MDR, after 20 March 2023 trigger the extension of the transitional period?
A:          Products placed on the market after 20 March 2023 under Article 59 or Article 97 of the MDR do not benefit from the extended transition period as they do not have valid certificates. Depending on national law, the decisions of national authorities might be adapted.

6.2         Can a device for which a derogation was granted in accordance with Article 59 MDR benefit from the transitional period even though it was required to not bear a CE marking?
A:          As long as the removal of the CE marking was a condition or consequence imposed by the national authority for an derogation under Article 59 MDR, the product may be placed on the market with a CE marking, as long as all other conditions are fulfilled.

9.1         What happens if the application is withdrawn or the written agreement terminated?
A:          The transition period no longer applies if the manufacturer withdraws its application for conformity assessment or the written agreement between the notified body and the manufacturer is terminated. However, if the manufacturer or the notified body terminates the written agreement and the manufacturer simultaneously enters into a written agreement with another notified body to which the application is transferred, the conditions referred to in Article 120(3c)(e) (MDR) shall continue to be fulfilled and the transitional period shall continue to apply, provided that the other conditions are also fulfilled.

9.2         What is the impact of changes related to the manufacturer during the transitional period?
A:          Administrative changes affecting the form of organization can generally be made without affecting the transition period. This includes, for example, the change of the name, address and legal form of the manufacturing company. Not covered are cases in which the manufacturer certified under the old MDD/AIMDD directives transfers products for which it holds a corresponding certificate to another manufacturer who wishes to place these products on the market.

11.1       Do legacy devices have to comply with UDI requirements during the extended transitional period?
A:          No. According to MDCG 2019-513, legacy devices are not subject to the UDI requirements of the MDR. This approach is not changed by the requirement that the manufacturer of the end-of-life device must establish an MDR-compliant QMS by 26 May 2024.

A detailed record of all minor additions made with revision 1 can be found in the change history on page 2 of the document.

Source:

EC: Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607