Extension of the transition period: the proposal to amend the European regulation 2017/745 MDR
The proposal to amend the European Regulation 2017/745 MDR and the European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting came earlier than expected and was already published on the European Commission’s Medical Device website on January 6.
The main objective of the European Medical Device Regulation (MDR) 2017/745 is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of safety and health, while supporting innovation.”
The transition period under Article 120(3) MDR will end on May 26, 2024.
The applied regulation of IVDRs
In January 2022, for in vitro diagnostics (regulated on May 26, 2026), the European Parliament and Council decided to adopt a staggered extension of the transition period:
- May 26, 2025: high-risk in vitro diagnostics;
- May 26, 2027: low-risk in vitro diagnostics;
- May 26, 2028: provisions for devices manufactured and used in healthcare institutions.
The MDR extension proposal
Despite progress, the overall capacity of notified bodies remains insufficient, in meeting all certification applications received, on time. In addition, many manufacturers are not sufficiently prepared in meeting MDR requirements by the end of the transition period.
This puts the availability of medical devices in the union market at risk.
The objective of the proposal is to maintain access to a wide range of medical devices and to ensure the transition to the new regulatory framework.
Therefore, the proposal aims to extend the transition period under Article 120, MDR. This would allow notified bodies and manufacturers more time to conduct evaluation procedures.
The extension of the transition period will be combined with the extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2), MDR.
Devices can then be placed on the market until the stipulated dates:
- Dec. 31, 2027: for class III medical devices and class IIb implantable medical devices; except sutures, staples, dental fillings, orthodontic appliances, screws, wedges, plates, wires, pins, clips and connectors;
- Dec. 31, 2028: Class IIb (other than those mentioned above), IIa and I devices.
The extension will be granted only if the following requirements are met:
- Medical devices that do not present unacceptable health and safety risks;
- Medical devices that have not undergone significant changes in design and/or intended use;
- Adaptation of the quality management system;
- Submission and/or acceptance of the manufacturer’s application for conformity assessment to a notified body before May 26, 2024.
Custom-made implantable class III devices: will an extension period be granted?
For Class III custom-made implantable devices, no transition period was granted, however, the proposal, by way of derogation from Article 5, provides that such devices may be placed on the market until May 26, 2026 without a certificate issued by a notified body for the conformity assessment procedure.
Provided that the manufacturer/licensee has submitted a formal application, by May 26, 2024, for the applicable conformity assessment and that by September 26, 2024, the notified body and the manufacturer/licensee have signed a written agreement (according to Section 4.3, second paragraph, of Annex VII).
Will the extension also be applied to certificates that have already expired?
The extension will also be granted to CE certificates that have already expired as of May 26, 2021, but only if one of the following conditions is met:
- The extension would be subject to the condition that at the time of expiration the manufacturer has signed a contract with a notified body to renew the certificate;
- Where a contract for certificate renewal has not been signed, a national competent authority may grant a waiver of the conformity assessment procedure (under Article 59 MDR) or require the manufacturer to carry out conformity assessment within a specified time (under Article 97 MDR).
Elimination of the sell-off period
For both medical devices and in vitro diagnostics, it is proposed to delete the sell-off period, i.e., the end date for further making available devices/diagnostics already placed on the market before or during the end of the transition period. This would eliminate the unnecessary disposal of safe devices/diagnostics already placed on the market.
The initiative aims to ensure patients across Europe have access to medical devices, so this proposal was supported by urgent requests from the European Parliament, member states and stakeholders.
Now the proposal will have to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.
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