MDCG NEWS: MDCG 2022-18 ADD.1 - Position Paper on the Application of Article 97 MDR to Legacy Devices with Expired MDD or AIMDD Certificates
Addendum 1 - June 2023
The MDCG published the position paper MDCG 2022-18 in December 2022 to establish a consistent approach for applying Article 97 of the MDR (Regulation (EU) 2017/745) in situations where MDD or AIMDD certificates have expired or will expire before obtaining the necessary MDR certificates. The purpose of using Article 97 MDR was to temporarily address this issue and prevent disruptions in the supply of medical devices crucial for healthcare systems and patients in the EU.
However, with the implementation of Regulation (EU) 2023/607 on March 20, 2023, the MDR transitional period and the validity of MDD/AIMDD certificates have been extended, subject to specific conditions outlined in the amended Article 120 MDR. This extension has successfully mitigated the immediate risk of shortages of critical legacy devices due to the expiration of MDD/AIMDD certificates. Consequently, the MDCG believes that the application of Article 97 MDR as described in MDCG 2022-18 is no longer relevant.
The MDCG recommends that national competent authorities (CAs) restrict the use of Article 97 MDR, as outlined in MDCG 2022-18, to only exceptional cases. For instance, this may apply if the national CA receives information justifying the application of Article 97 MDR before March 20, 2023. If a competent authority requires a manufacturer, in accordance with Article 97 MDR, to undergo the applicable conformity assessment procedure after March 20, 2023, the condition specified in Article 120(2), second subparagraph, point (b) of the MDR is not met. As a result, the expired certificate will not be considered valid, and the extended transitional period described in Article 120(3a) MDR will not apply.
Note: This revised version aims to improve the clarity and readability of the original text while retaining the essential information.
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