EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023)
On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about the extension period for MDR and IVDR.
At a glance, the acceptance of this proposal provides new timelines for MD and in vitro MD manufacturers to adapt their legacy devices portfolio to the new regulations:
- Class III custom-made implants which have Directive 90/385/EEC or Directive 93/42/EEC certificate, may be placed on the market or put into service until 26 May 2026.
- Class III and class IIb implantable devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) certified under Directives may be placed on the market or put into service until 31 December 2027.
- Other class IIb devices, class IIa devices and sterile or measuring class I devices, may be placed on the market or put into service until 31 December 2028.
- Self-certified Class I devices which would require NB assessment by MDR, may be placed on the market or put into service until 31 December 2028.
Moreover, sell-off date is removed for all medical and in vitro medical devices placed on the market with conformity to old Directives (before or during transitional periods). Therefore, they can be further made available or put into service without restrictions.
But don’t lower your guard yet, manufacturers. Be aware that all of these exciting provisions will be subjected to several cumulative conditions:
- To continue complying with Directives and have a valid certificate.
- The devices can not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health (in other words, the GSPR regulatory requirements should be met).
- Manufacturers must upgrade their QMS to comply with requirements set in Art. 10(9) of MDR before May 2024.
- Manufacturers must submit a formal application to NB asking for the conformity assessment of the corresponding legacy devices before May 2024. Also, before Sept 2024, they should present a signed agreement between them and the NB stating that devices will be re-certified under MDR before the transitional period ends.
- Compliance with MDR requirements for Post-Market Surveillance activities, Vigilance, Surveillance and registration process during transitional period is maintained.
For further information on how we can help, get in touch with our Medical Devices team