Exclusive: EU to propose delay to medical device law amid supply worries | Reuters
A few caveats. Class I & IIa would have until 2028 and Class IIb and III 2027
Those likely elements are based on the input received so far from national experts and stakeholders
and could include:
⮚ an extension of the transitional period in Article 120(3) MDR with staggered deadlines
depending on the risk class of the device. Those deadlines could be 2027 for class III and
class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e.
lower risk devices) that need the involvement of a notified body in the conformity assessment;
⮚ if needed for legal and practical reasons (including for access to third country markets), the
extension of the transitional period could be combined with an extension of the validity of
certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article
120(2) MDR;
⮚ conditions to be fulfilled in order to ensure that the extension applies only to devices that do
not present any unacceptable risk to health and safety, have not undergone significant changes
in design or intended purpose and for which the 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 certain
deadline (e.g. 26 May 2024);
A few caveats. Class I & IIa would have until 2028 and Class IIb and III 2027
Those likely elements are based on the input received so far from national experts and stakeholders
and could include:
⮚ an extension of the transitional period in Article 120(3) MDR with staggered deadlines
depending on the risk class of the device. Those deadlines could be 2027 for class III and
class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e.
lower risk devices) that need the involvement of a notified body in the conformity assessment;
⮚ if needed for legal and practical reasons (including for access to third country markets), the
extension of the transitional period could be combined with an extension of the validity of
certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article
120(2) MDR;
⮚ conditions to be fulfilled in order to ensure that the extension applies only to devices that do
not present any unacceptable risk to health and safety, have not undergone significant changes
in design or intended purpose and for which the 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 certain
deadline (e.g. 26 May 2024);
