As the medical device industry adapts to the evolving regulatory landscape, a critical deadline approaches for legacy medical device manufacturers to take advantage of the extended transition period for Regulation (EU) 2017/745 (MDR) compliance.
The European Union’s Regulation (EU) 2023/607, issued on 15 March 2023 and published five days later, grants an extension for certificates pertaining to legacy devices—those in conformity with Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) that are placed on the market after the MDR’s date of application (i.e. 26 May 2021).
Important Deadlines:
- 26 May 2024: Deadline for manufacturers to have filed a formal application for MDR conformity assessment to a notified body.
- 26 May 2024: Manufacturers must also have implemented a quality management system compliant with Article 10(9) of the MDR.
- 26 September 2024: A signed agreement with a notified body must be submitted for the extension to apply.
Additional conditions to benefit from the transition periods include:
- Devices continue to comply with AIMDD or MDD, as applicable;
- There are no significant changes in design and intended purpose;
- Devices do not present an unacceptable risk to patient, user or public health safety;
Remember, if your CE certificate under AIMDD or MDD has expired, you can prepare a self-declaration confirming compliance with the conditions mentioned above to benefit from the transition period proposed in Regulation (EU) 2023/607. Request this declaration from your notified body or use the template jointly developed by AESGP, COCIR, EuromContact, EUROM VI Medical Technology, and MedTech Europe.
Transition Period Deadlines
| Transition Deadline | Affected Devices |
| 26 May 2026 | Custom-made implantable devices in class III |
| 31 December 2027 | Higher-risk devices This includes Class III devices and Class IIb implantable devices, excluding sutures, braces, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips and connectors. |
| 31 December 2028 | Medium and lower risk products This includes other class IIb products, class IIa products and products of classes ls, lm, lr. |
| No extension | Class I devices (other than ls, lm, lr) |
The sell-off period for existing products has also been abolished to allow medical devices already placed on the market to be made available beyond the original date of May 2025; without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.
Useful Resources
- Regulation (EU) 2023/607: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0607
- Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf
- TEAM-NB Position Paper New MDR Transition Timelines and Notified Body Capacity: https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1-20230810.pdf
- Manufacturer’s Declaration in relation to Regulation (EU) 2023/607: https://www.medtecheurope.org/wp-content/uploads/2023/06/230609-final_mdr_manufacturer-declaration.docx
Stay informed and prepared to ensure a seamless transition to the MDR.
Contact us for any queries: [email protected]
