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Last Updated on 06/11/2025 by Sarah Sarsby
The MHRA Regulating Medical Devices in the UK guidance sets out MHRA’s requirements (see Section 7) as augmented by April 2023 MHRA Implementation Guidance, press statements, and Statutory Instrument (including Explanatory Notes), It can be summarised as follows:
A Transition Date Matrix showing transition dates based on device class and legislation under which a device is currently registered is available on the next page. See also the June 2023 MHRA Infographic of the timelines for placement of CE-marked medical devices on the GB market.
| Device Class | Law | NI Market Transition (CE, MDD-MDR) | GB Market Transition[2] (CE to UKCA) | Conditions |
|---|---|---|---|---|
| Class III; Class IIb implantables (not sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors) | EU MDD | 31-Dec-27 | 31-Dec-27 | Certificate must have been valid on 26 May 2021; expired certificates must be deemed valid by EU (MHRA requires “EU MDR Article 120 Letter” declaring key conditions for certificate extension are met); this will apply to system and procedure packs if they contain a device in these classes. |
| Class IIb (non-implantable) and sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors; Class IIa; Class Is; Class Im | EU MDD | 31-Dec-28 | 30-Jun-28 (or Cert expiry, sooner of) | Certificate must have been valid on 26 May 2021; expired certificates must be deemed valid by EU (MHRA requires “EU MDR Article 120 Letter” declaring key conditions for certificate extension are met); although certificate validity will be extended to 31 Dec 2028 under EU MDR, these devices can only be placed on GB market until 30 June 2028 (for devices for GB market, new expiry date should be entered as “30-Jun-28”); this will include system and procedure packs that contain such devices unless they also include a Class III or Class IIb implantable device (in which case the validity date will be 31 Dec 2027 for NI, 30 June 2028 for GB). |
| Up-Classified Class I req. NB for EU MDR | EU MDD | 31-Dec-28 | 30-Jun-28 | Dates relate to validity of Declaration of Conformity. |
| Class III, Class IIb, Class IIa | EU MDR | N/A | 30-Jun-30 | Technically, manufacturers may already apply a UKCA mark (for GB) to devices by working with UK ABs to obtain certification against UK MDR 2002. |
| Class I | EU MDD | N/A | N/A | EU MDD-to-MDR transition period for Class I devices not requiring NB involvement has expired; ergo, only devices with DoC to MDR should be placed on the GB market. |
| Class I | EU MDR | N/A | 30-Jun-30 | For Class I devices that are not up-classified and do not require NB involvement under EU MDR; technically, manufacturers may already apply a UKCA mark (for GB) to devices with DoC to UK MDR 2002. |
| Device Class | Law | NI Market Transition | GB Market Transition (UKCA) | Conditions |
| Class I-III medical devices | UK MDR | N/A | TBC | Transition dates to the new regulatory regime are expected to be provided in an SI to be laid before 1 July 2025 covering the balance of new medical device regulations; it is likely transition dates will be tied to the date this SI comes into force or the Inception Date of the new UK regime (expected 01-Jul-25). |
[2] Note: International reliance framework, to be introduced in 2025 will provide an alternative certification to UKCA marking in the GB, see section 2.
| IVD Class | Law | NI Market Transition (CE, IVD-IVDR) | GB Market Transition (CE to UKCA) | Conditions |
|---|---|---|---|---|
| Re-Classified to Class D | EU IVDD | 26-May-25 | 26-May-25 (or Cert expiry, sooner of) | Certificate or declaration of conformity must have been valid on 26-May-22; transitional arrangements for EU IVDR are based on the product risk classification under the EU IVDR |
| Re-Classified to Class C | EU IVDD | 26-May-26 | 26-May-26 (or Cert expiry, sooner of) | Certificate or declaration of conformity must have been valid on 26-May-22; transitional arrangements for EU IVDR are based on the product risk classification under the EU IVDR |
| Re-Classified to Class B or Class A (sterile) | EU IVDD | 26-May-27 | 26-May-27 (or Cert expiry, sooner of) | Certificate or declaration of conformity must have been valid on 26-May-22; transitional arrangements for EU IVDR are based on the product risk classification under the EU IVDR |
| General IVDs (that do not require involvement of a NB under EU IVDR) | EU IVDD | N/A | 30-Jun-30 (or Cert expiry, sooner of) | Declaration of conformity to IVDD requirements must have been made before 26-May-22 |
| Class D Class C Class B Class A (sterile) Class A | EU IVDR | N/A | 30-Jun-30 | No conditions |
| IVD Class | Law | NI Market Transition | GB Market Transition (UKCA) | Conditions |
| General IVDs, self-test IVDs, IVDs listed in Annex II list B, IVDs listed in Annex II list A | UK MDR | N/A | TBC | Transition dates to the new regulatory regime are expected to be provided in an SI to be laid in 2025 covering the balance of new medical device regulations; MHRA have indicated that they would like to establish a transitional arrangement for UKCA marked devices which will allow, at a minimum, products to be placed on the market until either the certificate expires or for 3 years after the new regulations take effect (in the case of general medical devices) or 5 years (in the case of IVDs), whichever is sooner. |
