The new Regulation on Medical Devices (MDR) entered into force in May 2021, replacing the previous Directive. Since then, many medical devices are subject to a transitional period. The initial transitional period foresaw that medical devices certified under the Directive could be placed on the EU market until May 26, 2024, if they met legacy requirements. A new decision just changed the scenario, bringing a longer transitional period and extended validity of CE certificates.
Challenges under MDR
The implementation of the MDR could bring to various challenges, which eventually would negatively affect health systems and patients. According to the first deadlines, from 2024, manufacturers could not place anymore their devices on the EU market if not certified under MDR. This would have lead to threaten the availability of certain medical devices and eventually to severe market disruptions. Moreover, the capabilities of notified bodies to assess the devices is insufficient compared to the upcoming large demand.
In this context of urgency, the Council and the European Commission met on December 9, 2022, to discuss new measures with the Member States. There was an overall agreement to move forward with the proposed changes.
New measures to implement the Regulation
In addition to the transitional provisions, the implementation of the MDR saw different measures. Especially, the measures aimed at preparing manufactures to the transition and enhancing notified bodies’ capacity. Among others, the measures included the implementation of hybrid audits, revisions of guidance documents, and redefinition of timing for re-assessments.
Despite many efforts from the EU and stakeholders, several Member States consider the actions undertaken so far not enough. Thus, Member States’ representatives spoke in favour of an extension of the transitional period.
Extension of transitional period and certificates
According to the decision taken on December 9, the new actions foresee:
- Extension of the transitional period:
a) 2027 for class III and class IIb devices
b) 2028 for class IIa and class I devices that need the involvement of a notified body in the conformity assessment
c) 2028 for class I sterile and class I with measuring function
- Extension of the transitional period could be combined with an extension of the validity of certificates issued under the Directives on medical devices and active implantable medical devices.
- Application of the new extensions only under certain conditions, namely:
a) devices that do not present any unacceptable risk to health and safety
b) devices that have not undergone significant changes in design or intended purpose
c) devices for which the manufacturers are already proceeding to the certification under MDR.
- Removal of the ‘sell off’ provision.
Follow up: what is next?
The legislative proposal should come at the very beginning of 2023. In the coming days, we can expect a position paper of the Medical Device Coordination Group (MDCG). Eventually, there will be an evaluation of the implementation by 2027.
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