Second Corrigendum to the MDR: A Christmas gift for manufacturers
The second corrigendum to Regulation (EU) 2017/745 on medical devices has brought a change in the wording of certain part of articles 78(8), 120(3), 120(4), 120(8) and 122; but what does it imply for the concerned economic operators?
The differences as regards to what was previously set out by the Regulation are significant for certain actors. Thus, if you are a manufacturer, an authorized representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3) thereof, reading this article is in the best of your interests.
A gift for manufacturers
If you produce a device which is a class I device under the Directive 93/42/EEC, for which the Declaration of Conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure pursuant to the Medical Device Regulation (MDR) requires the involvement of a Notified Body, this corrigendum is your stroke of luck. Provided such devices remain in full compliance with the Medical Device Directive (MDD) and there are no significant changes in the design and intended purpose, they may continue to be placed on the market until the 26th of May 2024, based on the modified Article 120(3) of MDR. This concerns in particular reusable surgical instruments which will require, at present, the intervention of a notified body in the conformity assessment procedure.
The delay will grant manufacturers extra time to identify a notified body designated under the MDR and perform their conformity assessment procedure. This tackles the shortage of notified body designated under MDR.
The MDR remains applicable to class I devices supplied not sterile and that do not incorporate a measuring function, which shall be fully compliant in May 2021.
Extra breathing room but…
Manufacturers should note that the exempted medical devices still need to comply with the MDD and certain articles of the MDR. Concerned products should not be subject to significant changes in the design or intended purpose between May 2021 until May 2024 and, more importantly, the MDR articles relating to post-market surveillance (Art.83-86), market surveillance (Art.93-100), vigilance (Art.87-92), and registration of devices (Art. 29) and economic operators and Art. 10-15 are applicable from 26th May 2021.
Carlos Francisco Marín Barrios
Regulatory Affairs and Quality Assurance Department
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