23.12.2022
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that on 9 December 2022, the European Commission published the MDCG 2022-18 Guidance on application of Article 97 of the MDR related to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.
„Legacy devices” are medical devices, active implantable medical devices and in vitro diagnostic medical devices covered by a valid EC certificate of compliance issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and which continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
In line with Article 94 of the MDR, if the assessment by the competent authorities of the member states of some medical devices, motivated either by the possibility of posing an unacceptable risk to the health or safety of patients, users or other persons, or which may affect public health or by non-compliance with another requirement of the MDR leads to finding the non-compliance of the medical device with certain requirements of the MDR (in this case, the lack of a valid EC certificate) but not to demonstrating unacceptable risks for the health or safety of patients, users or other persons, or which may affect public health, Article 97 of the MDR may apply.
The MDCG 2022-18 Guidance aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its 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 is meant to be a temporary solution. It will contribute to avoiding disruption of supply of devices on the EU market needed for health systems and patients.
It only applies to devices that are ‘in transition’ from the MDD or AIMDD to the MDR or, respectively, for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.
It does not apply to devices for which the certificate issued under the MDD or AIMDD has been suspended or withdrawn by the notified body; in other words, the Directive’s certificate must have been valid at the date of its expiry.
The announcement of the European Commission is available online at: https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en
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