· 5 min read
At the recent EPSCO meeting on December 9, 2022, The European Commission proposed new transition period extensions for the EU MDR. EU health ministers met to address the pressures currently on the MedTech industry including notified body bottlenecks with conformity assessments under the EU MDR/IVDR.
The European Commission’s proposal in the meeting was to extend transition timelines with Class III and Class IIb devices changing to 2027 and Class IIa and Class I devices changing to 2028. It also proposes to remove the sell-off provision in Article 120(4) MDR and Article 110(4) IVDR.
The recent MDCG 2020-18 position paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate has also been published.
Legacy devices are medical devices that manufacturers have legally placed on the market according to the directives such as MDD/AIMDD/IVDD and continue to place, but which may not meet the requirements of the MDR/IVDR. The current lack of capacity for conformity assessment procedures at notified bodies means that manufacturers are not receiving their MDR/IVDR certificates on time. However, according to Article 5 of the MDR, only medical devices whose conformity with the regulation has been proven may be placed on the market. The bottleneck at the notified bodies could therefore lead to a bottleneck in the supply of corresponding medical devices.
In order to counteract a shortage of medical devices due to a lack of capacity for conformity assessment procedures, the MDCG proposes in its position paper that medical devices that do not conform according to Article 5 can continue to be placed on the market using Article 97, provided that the responsible authority has assessed that the product does not pose any unacceptable risks.
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