Overview of EU Regulation 2023/607 transitional provisions

What are transitional provisions?
Transitional provisions are intended to provide more time for manufacturers of medical devices CE-marked under the Directives to acquire MDR CE certification.

These provisions are outlined under Art. 120  of MDR and on top of setting a timeframe for MDR conformity assessments, they are also intended to avoid shortages of medical devices that could jeopardize public health.

EU Regulation 2023/607

In March 2023, the EU Regulation 2023/607 entered into force to allow legacy medical devices that fulfill the additional conditions of Art.120 (as amended) to remain in the market till 2027/2028, subject to their classification. It is therefore a staggered extension of the transition periods provided for in the MDR, which is not applicable for class Is, Im, Ir medical devices, and combination products.

The 2023/607 Regulation extends the transitional provisions of the MDR as follows:

• 2026 for class III custom-made devices,
• 2027 for class III and class IIb implantable devices,
• 2028 for other class IIb, class IIa, and class Is, Im devices, and
• 2028 for class I up-classified devices.

The Regulation also removes the sell-off provisions of Art. 120(4) for both the MDR and IVDR, which means that devices already placed on the market can continue to be made available or put into service until the revised expiry of the certificate or until the shelf life of the device.

Applicable devices 

The 2023/607 Regulation only applies to devices, which meet the following criteria:

• The device continues to comply with the requirements of the Directives,
• The device does not and will not undergo a significant change to its design and intended purpose,
• The device does 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,
• The manufacturer will have an MDR-compliant QMS in accordance with Art. 10(9) in place by 26 May 2024,
• The manufacturer or its authorized representative has lodged an application for MDR CE-certification with a notified body by 26 May 2024,
• The manufacturer has signed a written agreement with a notified body by 26 September 2024.

Important Notes:

1. The Directive-compliant devices whose certificates expire after 20 March 2023 can benefit from the extension provisions if they meet the above criteria.
2. Manufacturers with devices subject to national derogation subject to Art. 59 (permanent derogation from the CE-marking process for reasons of public health) or Art. 97 (temporary derogation subject to the prerogative of Member State(s)), must be in contact and agreement with local Regulatory Authorities.
3. MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators, and reporting of serious adverse events and device deficiencies observed during clinical investigations shall be carried out in line with the MDR for all devices including the ones subject to transitional provisions

Useful Resources

1. EU REgulation 2023/607: See in link
2. Q&A on practical aspects related to the implementation of EU Regulation 2023/607: See in link
3. Flowchart to assist manufacturers in determining if their devices are covered by EU Regulation 2023/607: See in link
4. Team-NB position paper: Transfer Agreement for surveillance of legacy devices aac. to Art 120(3e): See in link