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.