Entry into force of Regulation (EU) 2023/607 (Amendment to MDR and IVDR)
Regulation (EU) 2023/607 has officially entered into force as of 20th March 2023, following its publication in the Official Journal of the European Union. This important update comes as result of the amendment that was proposed in January of this year, and is intended to address issues such as limited notified body capacity, potential device shortages, and the state of preparedness of medical device manufacturers.
What does this mean?
This amendment results in an extension of the MDR transition period for certain medical devices, as follows:
• Class III and class IIb implantable devices - December 2027
• Class IIb non-implantable, class IIa, and class I devices - December 2028
Additionally, the sell-off date provision for existing products according to MDR and IVDR has been abolished, meaning that devices that have already been placed on the market will no longer need to be discarded by May 2025, as per the original provisions of MDR and IVDR.
What do we need to know?
While it’s likely that this news will positively impact the majority of manufacturers in some way, it’s important to note that there are some provisions that apply in order to take advantage of the extension:
• this transition extension only applies to legacy devices that already hold a notified body certificate under the MDD or the AIMDD, as applicable;
• No significant changes can be made to the legacy devices within the transition period;
• A conformity assessment application must be made to a notified body prior to 26th May 2024, and a contract must be in place by 26th September 2024;
• The extension does not apply to QMS requirements, which must be met by May 2024;
• Post-market surveillance requirements apply, and any newly identified risks to device safety could result in the cancellation or withdrawal of the existing legacy certificate.
It is widely advised that manufacturers do not take this as an opportunity to relax their efforts in meeting the requirements of the regulation. Notified body capacity remains an issue and therefore, submissions should be made as soon as possible to avoid excessive waiting periods as demand inevitably increases.
Our seasoned experts are on hand to support all MDR and IVDR compliance activities including:
Gap analysis and remediation of technical documentation
Readiness audits (QMS and technical documentation)