The Proposal Amendments
The proposal has 3 articles:
- Article 1 – Amendments to Article 120(2), (3) and (4) and to Articles 122 and 123 of the MDR.
- Article 2 – Amendments to Article 110(4) and to Article 112 of the IVDR.
- Article 3 – Entry into force and application
Amendments to MDR
Transition period extension
The validity of the certificates issued under the Directives that were valid on 26 May 2021 was extended. If the certificates have already expired when the proposed amendment enters into force, the extension is only applicable if the manufacturer has a signed contract with a notified body for the conformity assessment at time of the expiry.
The transition period is extended until 31 December 2027 for higher risk devices (class III and class IIb implantable devices) and until 31 December 2028 for medium and lower risk devices (other class IIb devices and class IIa, class Im, Is and Ir devices).
The amendment also introduces a transition period until 26 May 2026 for class III custom-made implantable devices.
Conditions for the transition period
The extended transition period applies only to ‘legacy devices’.
Moreover, the application of the extended transition period is subject to the following cumulative conditions:
- The devices must continue to comply with the Directives
- The devices do not significantly change their design and intended purpose
- The devices do not present an unacceptable risk to the health or safety of patients, users, other persons, or public health
- No later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) according to the MDR.
- No later than 26 May 2024, the manufacturer has lodged a formal application for conformity assessment according to MDR, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement
The devices covered by a certificate issued according to the Directives remain subject to appropriate surveillance by the notified body that issued the certificate. However, the manufacturer can agree that this becomes responsibility of the notified body designated under the MDR.
Deletion of the sell-off provision
Devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.
Amendments to IVDR
Devices placed on the market before the end of the transition period (May 26 2027 for class A sterile and B, May 26 2026 for class C and May 26 2025 for class D) can be made further available on the market without a legal time restriction.
If you wish to get more information about the provisions of the EU-MDR and the EU-IVDR, feel free to contact us at email@example.com.