On June 30th, 2023, the Medical Device Coordination Group (MDCG) released Addendum 1 to the position paper MDCG 2022-18 on the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) to legacy devices for which the 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR. The newly published addendum clarifies that with the adoption of Regulation (EU) 2023/607, the amendment to the MDR, the application of Article 97 of the MDR should be limited to very exceptional situations.
The use of Article 97 of the MDR in those situations was meant to be a temporary solution and the original goal of the position paper was to contribute to avoid disruption of supply of devices on the EU market needed for health systems and patients.
With the entry into force of Regulation (EU) 2023/607 on March 20th; 2023, the MDR transitional period and the validity of MDD/AIMDD certificates have been extended, provided that the conditions in the amended Article 120 MDR are met.
Regulation (EU) 2023/607 has averted the imminent risk of shortages of critical legacy devices related to the expiry of MDD/AIMDD certificates. The MDCG therefore considers that the application of Article 97 MDR in accordance with MDCG 2022-18 to situations where a MDD/AIMDD certificate has expired prior to the issuance of a MDR certificate has achieved its objective and is not relevant any more.
What does this mean to you?
MDCG 2022-18 Add.1 is relevant for MD manufacturers who have legacy devices with MDD/ AIMDD certificates that have not yet transitioned to MDR.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.