Proposed changes of MDR transition times/in News from QAdvis, startpage /by Johnnie Dahlberg
EU Commission is proposing elements of a bridging measure for MDD certificates that expire pending MDR conformity assessment
A Commission proposal for bridging measures for certificates that expire pending MDR conformity assessment was on the agenda for the EPSCO meeting on December 9, 2022. The proposal suggests an extension of the transition time for legacy devices under MDR 2017/745 Article 120(3) by risk class to the year (dates not specified yet):
- 2027 – Class III
- 2027 – Class IIb
- 2028 – Class IIa
- 2028 – Class I devices that need involvement of a Notified Body in the conformity assessment
The extension of transition time could possibly be combined with an extension of validity of certificates issued under MDD by amending MDR Article 120(2).
Conditions for extension:
- devices must not present any unacceptable risk to health and safety;
- devices have not undergone significant changes in design or intended purpose;
- manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a deadline still to be proposed.
Also, it was proposed to remove the “sell-off” provision in Article 120(4) and the corresponding Article 110(4) of IVDR 2017/746 enabling distribution of legacy products until stock is empty.
Although no concrete dates have yet been revealed, a new position paper has been published in the form of MDCG 2022-18 right after the EPSCO meeting. According to this position paper, if certification of devices under the MDR has not been finalized before expiry of the Directive’s certificate, and if the device does not present an unacceptable risk to health and safety, Article 97 of MDR enables Competent Authorities to require the relevant manufacturer, or its authorized representative, to bring the non-compliance to an end within a reasonable and clearly defined period. This might limit the impact of NB resource insufficiencies on the supply of safe and effective devices to patients and healthcare providers.
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