The following table details the current transition timelines for medical devices and IVDs.
Classification | Applied to a notified body | Written agreement from notified body | Transition ends |
Class III and custom-made implantable | 26 May 2024 | 26 September 2024 | 31 December 2027 |
Devices covered by a valid MDD/AIMDD certificate (valid as 20 March 2023) that are class III, class IIb implantable devices (excluding well-established technologies) | 26 May 2024 | 26 September 2024 | 31 December 2027 |
Devices covered by a valid MDD/AIMDD certificate (valid as 20 March 2023) that are class IIb (excluding class IIb implantable non-well-established technologies), or class IIa, or class I sterile, or class I measuring | 26 May 2024 | 26 September 2024 | 31 December 2028 |
Device that did not require notified body certification under the MDD and for which the declaration of conformity was drawn up prior to 26 May 2021 (but now require notified body certification) | 26 May 2024 | 26 September 2024 | 31 December 2028 |
Devices covered by a valid IVDD certificate | 26 May 2025 | 26 September 2025 | 31 December 2027 |
Class D | 26 May 2025 | 26 September 2025 | 31 December 2027 |
Class C | 26 May 2026 | 26 September 2026 | 31 December 2028 |
Class B and A-sterile | 26 May 2027 | 26 September 2027 | 31 December 2029 |
Note that classifications for medical devices are based on the classification of the device under the MDD or AIMDD. For IVDs, the classification is based on classifications under the IVDR.
The time taken to conduct conformity assessment is variable dependent on numerous factors including the novelty, complexity, risk level, and capacity of the notified body. Typically, it can take between 9 months to 24 months for conformity assessment to be completed, but in some cases may be longer.