Last Updated on 22/08/2023 by Sarah Sarsby
The guidance at MHRA – Regulating Medical Devices in the UK sets out MHRA’s requirements (see Section 7 below for more details); as augmented by Apr-23 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 Jun-23 MHRA Infographic of the timelines for placement of CE-marked medical devices on the GB market.
| Device Class | Law | NI Mkt Trans (CE, MDD-MDR) | GB Mkt Trans (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-21; 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-21; 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-28 under EU MDR, these devices can only be placed on GB market until 30-Jun-28 (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-27 for NI, 30-Jun- 28 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, Mfrs 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, Mfrs may already apply a UKCA mark (for GB) to devices with DoC to UK MDR 2002 |
| Device Class | Law | NI Mkt Trans | GB Mkt Trans (UKCA req’d) | Conditions |
| Class I-III | New UK MDR | N/A | TBC | Transition dates to the new regulatory regime are expected to be provided in an SI to be laid before 01-Jul-25 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 (currently 01-Jul-25) |
New UK IVD Regulation – Transition Date Matrix [as at Aug-23]
| IVD Class | Law | NI Mkt Trans (CE, IVD-IVDR) | GB Mkt Trans (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 Mkt Trans | GB Mkt Trans (UKCA req’d) | Conditions |
| General IVDs, self-test IVDs, IVDs listed in Annex II list B, IVDs listed in Annex II list A | New UK MDR | N/A | TBC | Transition dates to the new regulatory regime are expected to be provided in an SI to be laid before 01-Jul-25 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) |