The position paper MDCG 2022-18 was published in December 2022 to provide a
uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on
medical devices (MDR) in situations where a certificate issued under Directive
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 use of
Article 97 MDR in those situations was meant to be a temporary solution. The goal of
the position paper MDCG 2022-18 was to contribute to avoiding 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 20 March 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…
