The MDCG released an addendum to MDCG 2022-18: HERE

Original Purpose of MDCG 2022-18

The original purpose of MDCG 2022-18 was to provide guidance for manufacturers with expiring MDD/AIMDD CE Marking, on how to leverage MDR Article 97 to continue marketing with expired CE Certificates. The intent was to provide a bridging measure until the EU legislation was amended to extend the MDR’s transition period.

For a more background on MDCG 2022-18, please read: Guidance for MDD/AIMDD Manufacturers with Expiring Certificates

Purpose of the New Addendum

The addendum clarifies that with the implementation of Regulation (EU) 2023/607, the “imminent risk of shortages of critical legacy devices related to the expiry of MDD/AIMDD certificates” has been averted. Therefore, the MDCG no longer considers the application of MDR Article 97 relevant for this purpose.

The MDCG “recommends that national CAs limit the application of Article 97 MDR as set out in MDCG 2022-18 to very exceptional situations, e.g. where the national competent authority (CA) has received information justifying the application of Article 97 MDR prior to 20 March 2023.”

Essentially, the MDCG advises that manufacturers should no longer submit Article 97 requests due to an MDD/AIMDD CE Certificate having expired. Regulation 2023/607 already covers this scenario. And if the device does not meet the extension caveats outlined in Regulation 2023/607, then the device is not considered eligible for the MDR’s transition provisions under Article 120(3a).

Switzerland 

Swissmedic had already made this statement on 30 March 2023, when they announced they would recognize the EU MDR’s transition period extension: “Thus, the issuing of confirmation letters in accordance with the EU position paper MDCG 2022-18 is now also unnecessary in Switzerland.”