we would like to inform you about conditions for extension of the validity period of your EC certificates related to the medical devices, certified as per Directive 93/42/EEC as amended - the so-called “legacy devices”, stated in the recently adopted Regulation (EU) No. 2023/607 of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
In order to automatically benefit from the extension of your EC certificate validity period related to the “legacy devices”, following conditions have to be cumulatively met before expiry of the mentioned EC certificates:
ü no later than 26 May 2024, the manufacturer (or its authorised representative), has lodged a formal application with attachments as per Annex IX, point 2.1 of the MDR for conformity assessment in respect of a “legacy device“ covered by a EC certificate together with submission timeline of complete technical documentation prepared in line with Annex II and III of the MDR, and no later than 26 September 2024 we as the notified body and the manufacturer have signed a written agreement related to the conformity assessment of this „legacy device“ according to the MDR,
ü no later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with MDR
ü the “legacy device” must continue to comply with Directive 93/42/EEC as amended, as applicable,
ü the „legacy device“ does not undergo significant changes in the design and intended purpose,
ü the „legacy device“ does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.
If these requirements are fulfilled, we as a notified body will perform surveillance audits for the „legacy devices“ stated in the MDR written agreement (even for “legacy devices” where other MDD notified body issued EC certificate as per Directive 93/42/EEC as amended).
If these requirements are not fulfilled cumulatively, EC certificates related to “legacy device” do not remain valid after the end of the period indicated on certificates and only MDR certified medical devices may be placed on the market or put into service.
If your EC certificate has already expired before entry into force of the above mentioned Regulation and you did not sign the written agreement related to “legacy device” with notified body before the expiry date, you may ask competent authority for derogation from the applicable conformity assessment procedure in accordance with Article 59(1) MDR or 97(1) MDR.