MDR transitional provisions
This webpage provides information for stakeholders on the transitional provisions of the Medical Devices Regulation (MDR).
What are transitional provisions?
Transitional provisions allow time for devices CE marked under the Directives to transition and become CE marked under the MDR.
The provisions outlined under Article 120 give enough time for devices to undergo conformity assessment under the MDR. They also aim to avoid device shortages.
Extension to MDR transitional provisions
On 20 March 2023, Regulation (EU) 2023/607 entered into force.
This 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 provision’ for both the MDR and IVDR. This 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.
We recommend you read the Regulation to understand how it may affect your organisation.
The Commission developed a Q&A document. This gives practical information on the application of the extension.
Does the extension apply to all Directive-compliant devices?
The extension only applies to devices which meet the criteria outlined in Regulation (EU) 2023/607 as follows:
- the device continues to comply with the previous Directives,
- the device does 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 has a QMS in accordance with Art 10(9) in place by 26 May 2024,
- the manufacturer or authorised representative has lodged an application for MDR certification with a notified body by 26 May 2024,
- the manufacturer has signed a written agreement with a notified body by 26 September 2024.
Directive-compliant device where its certificate expires after 20 March 2023
- If the device meets the relevant criteria, it will benefit from the extension.
Directive-compliant device where its certificate expires before 20 March 2023
- If the device has been subject to a national derogation in accordance with Article 59 or Article 97, please email us directly at firstname.lastname@example.org for more information.
Do MDR requirements apply to devices subject to transitional provisions?
MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices apply to devices subject to transitional provisions.
The reporting of serious adverse events and device deficiencies observed during clinical investigations must be carried out in line with the MDR.
When do I need to place a UDI carrier on my medical device?
Article 27(4) notes that manufacturers must place UDI carriers on the label of devices and on all higher levels of packaging.
Article 123 of the MDR sets out a number of soft provisions which cover the phased application of device labelling and UDI carriers.
Separate timelines will apply for reusable devices required to bear the UDI carrier on the device itself. We provide a summary of UDI timelines in the table below.
For more details about MDR transitional provisions, please go to the MDCG’s homepage.