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4. UK medical device regulation – transition date matrix

Last Updated on 22/08/2023 by Sarah Sarsby

Medical device - hearing aid image

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:

  • Inception Date:  “Core aspects” of the new UK medical device regime expected to come into effect 01-Jul-25
  • Transitional Arrangements – Devices CE-Marked Under EU MDR or EU IVDR:  Medical devices CE-marked under EU MDR or EU IVDR may stay on the GB market until 01-Jul-30
  • Transitional Arrangements – Devices CE-Marked under EU MDD:  Medical devices CE-marked under EU MDD may stay on the GB market until the sooner of current CE certificate expiry or for 3 years after new regulations take effect (i.e. until 01-Jul-28)
  • Transitional Arrangements – Devices CE-Marked under EU IVDD:  Medical devices CE-marked under EU IVDD may stay on the GB market until the sooner of current CE certificate expiry or until 1-Jul-30
  • CE-Marked Class I Medical Devices:  Standard Class I medical devices CE-marked under EU MDR – i.e. those that do not/will not need  3rd-party assessment– will benefit from the EU MDR Transitional Arrangement above, and may stay on the GB market until 01-Jul-30 (NB – the EU MDD-to-MDR transition period for Class I devices not requiring 3rd-party assessment has expired; ergo, only devices with Declaration of Conformity (DoC) to MDR should be placed on the GB market)

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.

New UK medical device regulation – Transition date matrix [as at Aug-23]

Device ClassLawNI 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 MDD31-Dec-2731-Dec-27Certificate 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 ImEU MDD31-Dec-2830-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 MDREU MDD31-Dec-2830-Jun-28Dates relate to validity of Declaration of Conformity
Class III
Class IIb
Class IIa		EU MDRN/A30-Jun-30Technically, Mfrs may already apply a UKCA mark (for GB) to devices by working with UK ABs to obtain certification against UK MDR 2002
Class IEU MDDN/AN/AEU 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 IEU MDRN/A30-Jun-30For 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 ClassLawNI Mkt TransGB Mkt Trans
(UKCA req’d)		Conditions
Class I-IIINew UK MDRN/ATBCTransition 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 ClassLawNI Mkt Trans
(CE, IVD-IVDR)		GB Mkt Trans (CE to UKCA)Conditions
Re-Classified to Class DEU IVDD26-May-2526-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 CEU IVDD26-May-2626-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 IVDD26-May-2726-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 IVDDN/A30-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 IVDRN/A30-Jun-30No conditions
IVD ClassLawNI Mkt TransGB Mkt Trans
(UKCA req’d)		Conditions
General IVDs, self-test IVDs, IVDs listed in Annex II list B, IVDs listed in Annex II list ANew UK MDRN/ATBCTransition 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)