On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation.  The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices in Great Britain, with this consultation expected to take place later in 2025.

Background

The MHRA ran a consultation from November 2024 to January 2025 covering a range of proposals related to the regulation of medical devices in Great Britain, including (i) international reliance, (ii) UKCA marking, (iii) in vitro diagnostic device (“IVD”) requirements, and (iv) a proposal to remove the revocation date (26 May 2025) for four pieces of assimilated EU law so that they remain part of the statutory framework for medical devices in Great Britain (please see our prior blog post here).    

With respect to point (iv), the MHRA published a partial response to the consultation in February 2025 and subsequently actioned this to ensure the assimilated EU legislation (Commission Decision 2002/364; Commission Regulation (EU) No 207/2012; Regulation (EU) No 722/2012; and Regulation (EU) No 920/2013) remained in force until such time as it is replaced with updated UK law.

The consultation response published this month relates to the three other categories of proposals.  It is relevant for medical devices placed on the market in Great Britain.  Although part of the UK, medical devices intended for the Northern Ireland market must comply with the EU Medical Devices Regulation 2017/745 (“EU MDR”) or EU In Vitro Medical Devices Regulation 2017/746 (“EU IVDR”), as applicable, by virtue of the Northern Ireland Protocol.

International Reliance

The MHRA first announced its intention to introduce UK recognition of international regulatory approvals for certain medical devices in May 2024 (please see our prior blog post here).  The outcome of this recent consultation provides more detail on the scheme that will now be implemented. 

The core concept is that the MHRA will rely on the approvals or certificates issued in respect of medical devices by the regulatory authorities in certain comparable regulator countries (“CRCs”) to enable access to the market in Great Britain, subject to certain conditions and requirements.  These CRCs are as follows:

• Australia;
• Canada;
• EU/EEA; and
• USA.

To be eligible for any of the access routes under the international reliance scheme (set out below), devices must:

• fall within the scope of the UK Medical Devices Regulations 2002, as amended (“UK MDRs”);
• be classified in accordance with the UK MDRs;
• have English language labelling and packaging;
• be supplied with an implant card and leaflet in compliance with the requirements in the UK MDRs, where applicable;
• comply with all other relevant product requirements applicable in Great Britain, such as those for machinery, electronics compatibility, units of measurement, and labelling materials of concern where applicable (for example, for substances which are carcinogenic, mutagenic or toxic to reproduction or could result in sensitization or an allergic reaction);
• have a UK Responsible Person, the name and address of which should be included on the product labelling or the outer packaging, or the instructions for use (this may be via over-labelling, and the MHRA will also investigate the possibility of digital labelling solutions in a future consultation);
• have a physical unique device identifier (“UDI”) on parts and labels in compliance with the (updated) requirements of the UK MDRs or the CRC;
• comply with the post-market surveillance (“PMS”) requirements in the UK MDRs; and
• be registered with the MHRA.

The MHRA initially proposed four specific access routes for different device classes and types under this international reliance scheme.  Following the consultation, the Government intends to proceed with implementing three of these international reliance routes, which we detail below.  The original proposals for international reliance included devices that comply with EU devices legislation (e.g., the EU MDR and EU IVDR).  However, the MHRA noted that many consultees requested the indefinite extension of recognition of CE marked devices.  As a result, the MHRA intends to consult further on the international reliance routes for CE marked devices and will not implement the proposed routes for such devices at this stage.  Routes 1, 3 and 4 below are therefore relevant only to devices that comply with legislation in Australia, Canada or the USA, as applicable.

Route 1

• Eligible devices – The following low risk devices that comply with devices legislation in Australia, Canada or the USA will be eligible for Route 1:
  • Class I medical devices (other than Class I sterile devices or Class I devices with a measuring function); and
  • Class A non-sterile IVDs.

• GB requirements – Under Route 1, no UK Approved Body review will be required in relation to the device, but the device manufacturer must self-declare that it has an appropriate Quality Management System (“QMS”) to the MHRA during registration. 

Route 3

• Eligible devices – The following non-active devices that comply with device legislation in Australia, Canada (using Class III or Class IV licence) or the USA (using De Novo, PMA or 510(k)) will be eligible for Route 3 (excluding devices listed under Route 4 below):
  • Class I sterile devices and those with a measuring function;
  • Class IIa, IIb and III devices (for devices from Canada, only devices with a Class IV licence in Canada would be able to enter this route as a Class III device in Great Britain);
  • Sterile Class A IVDs; and
  • Class B and C IVDs.

• GB requirements – Under Route 3, the medical device will still require a UK Approved Body to:

1. Confirm its marketing authorization in the relevant CRC;
2. Confirm its classification under the medical device rules in Great Britain;
3. Confirm the applicable requirements under the medical device rules in Great Britain;
4. Review the PMS plan;
5. Review PMS data from the previous five years where available;
6. Confirm that the implant card and patient leaflet, if applicable, meet the relevant requirements under the UK MDRs; and
7. Confirm that the instructions for use provided with reusable devices, if applicable, contain information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization, and any restriction on the number of reuses.

Route 4

• Eligible devices – The following devices will be eligible for Route 4:
  • Class IIa, IIb (non-implantable) and IIb non-resorbable sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors that comply with 510(k) legislation in the USA;
  • Medical devices that incorporate an ancillary medicinal substance from Australia, Canada (using Class III or Class IV licence (although for devices from Canada, only devices with a Class IV licence in Canada would be able to enter this route as a Class III device in Great Britain)) or the USA;
  • Class D IVDs that comply with devices legislation in Australia, Canada or the USA;
  • Active devices that comply with devices legislation in Australia, Canada (using Class III or Class IV licence (although for devices from Canada, only devices with a Class IV licence in Canada would be able to enter this route as a Class III device in Great Britain)), or the USA (using De Novo, PMA or 510(k)).

• Additionally, the MHRA’s consultation response confirms an expansion of the proposed scope of Route 4 to include software as a medical device and implantable Class IIb and Class III medical devices that comply with 510(k) legislation in the USA, subject to the demonstration of entire equivalence.

• GB requirements – Under Route 4, the medical device will still require a UK Approved Body to:

1. Perform steps (a) to (g) for Route 3 above;
2. Confirm that the rationale for equivalence to a “reference device” for 510(k) devices meets the requirements of the UK MDRs;
3. Obtain an opinion on the quality and safety of any ancillary medicinal substance incorporated into the device from the Secretary of State;
4. Confirm Class D IVDs meet batch test release requirements;
5. Confirm active devices are compatible with electrical requirements in Great Britain;
6. For software as a medical device, review information that demonstrates there are no differences between the CRC and Great Britain that adversely impact on the safety or efficacy of the device and the appropriateness of any pre-determined change control plans.

The MHRA confirmed that it will issue guidance to address the details regarding the operation of the routes under the international reliance procedure, including specific requirements that will apply to software and Class D in vitro diagnostic devices.

Removal of UKCA Marking Requirements

Under the UK MDRs, manufacturers affirm that the device has completed the relevant conformity assessment procedure by drawing up a declaration of conformity, and affixing the UKCA mark to the product and its associated labelling. Following the consultation, the MHRA has confirmed its intention to remove the requirement for such UKCA marking once a UDI is in place.  The rationale behind this change is to reduce the regulatory burden on manufacturers while improving traceability and PMS through the use of UDIs.   Each UDI will be unique to the relevant medical device itself, which will allow the MHRA and users of the MHRA’s Public Access Registration Database (“PARD”), to identify the device, which entity manufactured the product, and who placed it on the market. 

However, UKCA marking requirements under other relevant legislation will continue to apply for devices subject to such legislation, including for electrical equipment safety and restriction of the use of certain hazardous substances (“RoHS”) in electrical equipment. 

Class B IVDs

The consultation included the MHRA’s proposal to amend the conformity routes to market for Class B IVDs.  Under the proposed classification system, Class B IVDs would require both a UKCA self-declaration of conformity and QMS certification to ISO 13485 issued by a UK Accreditation Service (“UKAS”) accredited body.  This proposal was aimed at ensuring the market access requirements for low-medium risk IVDs are risk proportionate.

Following the consultation, the MHRA has confirmed its intention to proceed with this proposal, but with the additional flexibility for manufacturers to obtain QMS certification from International Accreditation Forum (“IAF”) accredited certification bodies from Comprehensive and Progressive Agreement for Trans-Pacific Partnership (“CPTPP”) countries, as well as UKAS accredited bodies.

However, recognizing concerns raised by consultees regarding the adequacy of pre-market controls and the potential for manufacturers to mis-classify products into Class B, the MHRA’s consultation response confirms that if more than one classification could apply to an IVD, the device will be required to adopt the higher classification.

Next Steps

The MHRA will amend the UK MDRs to incorporate the legislative changes set out in the consultation response.  The changes relating to international reliance and IVDs will be implemented in the “Pre-Market” medical device legislation currently in development.  The MHRA has confirmed that this Pre-Market legislation will be subject to World Trade Organization (“WTO”) notification requirements and brought into force as soon as Parliamentary time allows thereafter.  The MHRA expects to publish the draft legislation on the WTO website later this year.

This Pre-Market legislation will also introduce the requirement to assign a UDI to a device, the transitional period for which will be three years for general medical devices and five years for IVDs. Concurrently, the MHRA will develop separate legislation removing the requirement for UKCA marking, which will come into force after the proposed UDI database is operational and the transitional period for the introduction of UDIs has concluded.

Finally, the MHRA plans to issue a consultation regarding the indefinite recognition of CE marked medical devices later this year.  Irrespective of this planned consultation, devices CE marked under the EU MDR or EU IVDR will continue to be accepted in Great Britain until June 2028 or June 2030 (depending on the specific device).

If you would like to discuss the latest medical device developments in the UK (or EU) and what they may mean for your company’s operations, please contact: Sarah Cowlishaw, Roderick Dirkzwager or Dan Spivey.