Legacy devices may have more time to come into compliance with EU Medical Device Regulations (MDR). On December 9, the European Commission’s Medical Device Coordination Group (MDCG) issued the “MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate,” which lays out a “uniform approach” to Article 97 of MDR that would allow devices with expired certificates to remain on the market as they work to come into compliance with MDR.
If finalized, the Article 97 extension would apply to devices certified under MDD or AIMDD that do not present an unacceptable risk to health and safety.
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“Where, after having performed this evaluation pursuant to Article 94 MDR, the CA finds that the device does not comply with certain MDR requirements but does not present an unacceptable risk to health and safety of patients, users or other persons, or to other aspects of the protection of public health, Article 97 MDR is applicable,” the paper states. “In general, the period should not exceed 12 months, but could be extended in duly justified cases.”
The MDCG clarified that this would only apply 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.”