With the publication in the Official Journal of the European Union, the amendment to Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was approved.
This gives more time to many manufacturers and avoids the exit from the market of a significant number of medical devices and in vitro diagnostic medical devices. The Regulation (EU) 2023/607 introduces the following main changes:
- Extension of MDR transition period until 31 December 2027 for class III medical devices and class IIb implantable devices (with some exceptions);
- Extension of MDR transition period until 31 December 2028 for class IIa, IIb devices (not covered by previous point), class I sterile devices or with measuring function, as well as devices qualified as class I under the directives but which conformity assessment procedure under the MDR requires the intervention of a Notified Body;
- Removal of the “sell-off” period in the MDR and IVDR;
- Introduction of a transition period until 26 May 2026 for class III custom-made implantable devices.
The above-mentioned devices will be allowed to benefit from the extension if the following preconditions are satisfied:
– such devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
– there are no significant changes in design and intended use;
– the devices do not present an unacceptable risk to the health or safety of patients, users or other persons or to other aspects of public health protection;
– by May 26, 2024, the manufacturer has established a quality management system in accordance with Article 10(9) of the MDR;
– by May 26, 2024, The manufacturer – before the certificate’s expiration – has concluded a contract with a Notified Body for conformity assessment under the MDR or alternatively the manufacturer benefitted from an exemption under either Article 97 or 59 of the MDR, which provide derogations from applicable rules in particular cases.
Regulatory Pharma Net (RPN) is currently evaluating the impact of this new regulation on medical devices and in vitro diagnostic medical devices, directly involving the Notified Bodies. We are available to provide your company with any updates and to assist on all regulatory needs.
Feel free to contact us at info@regulatorypharmanet.com