In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in vitro diagnostic devices.
In the response, the UK government confirmed it will amend the UK Medical Devices Regulations 2002 to implement reforms of pre-market rules, including (i) implementing an international reliance framework, and (ii) updating the classification of in vitro diagnostic (IVD) devices.
What happened
The UK Medicines & Healthcare products Regulatory Agency (the MHRA) has identified four countries that have comparable regulatory systems to Great Britain (GB): the USA, Canada, the EU, and Australia. Following the consultation, the UK government has confirmed that it proposes to rely on the approvals by regulators in the USA, Canada, and Australia, subject to certain conditions.
The consultation had controversially proposed that, instead of recognition, EU certified devices would require further approval steps before being placed on the GB market. There have been widespread calls for indefinite continuation of the recognition of EU certified devices. The consultation acknowledges these industry requests and confirms that the proposals for EU certified devices will be dropped. A further consultation on market entry for EU certified devices is due to be issued later this year.
What is international reliance and international recognition?
The consultation outlines two paths to GB market which a manufacturer may choose instead of the UKCA assessment. These are:
- International recognition, which is the acceptance of the regulatory decision of another regulator or trusted institution without the need for further approvals, e.g., the current recognition of the CE-mark; and
- International reliance, where a lighter touch review is undertaken by UK approved bodies, and weight is given to assessments performed by another regulatory authority or trusted institution, in reaching its own decision.
International recognition – indefinite CE-mark recognition?
Currently, medical devices need to have a UKCA marking or a CE marking from the EU to be placed on the GB market. The arrangement for CE marked devices is time currently limited until 30 June 2028 or 30 June 2030, depending on the device.
The government consultation had proposed that instead of continued recognition, EU CE marked devices (other than Class I) would move to an international reliance model.
In its response, the UK government recognised that a recurring theme in the consultation responses was the request to indefinitely extend the recognition of CE marked medical devices in accordance with current transitional arrangements. In a step that will be widely welcomed by industry, the UK government has dropped the proposal to move CE marked devices to the international reliance route and has said it will consult on international routes for CE marked devices in due course.
If the UK government, following this future consultation, decides to extend the CE-mark recognition for medical devices indefinitely, this will be widely welcomed by the med tech industry. Continuation of indefinite recognition would alleviate the regulatory burden of double certification and simplify access to the UK market.
International reliance – USA, Canada, and Australia
The UK government has confirmed that for Australia, Canada, and the USA, it will legislate to allow for reliance on the approvals or certificates issued by the regulatory authorities in these comparable regulator countries (CRCs).
Under the proposed framework, this is proposed to be a streamlined review and may allow for swifter market access for these devices.
To be eligible for streamlined review, the medical devices must:
- fall within the scope of the UK Medical Devices Regulations;
- be classified in accordance with UK Medical Devices Regulations;
- have English language labelling and packaging;
- be supplied with an implant card and leaflet in compliance with the requirements in the new UK Medical Devices Regulations, where applicable;
- comply with GB requirements for all other relevant product requirements such as those for machinery, electronics compatibility, units of measurement, and labelling materials of concern where applicable;
- have a UK Responsible Person, the name and address of which would be included on the product labelling or the outer packaging, or the instructions for use;
- have a physical unique device identifier (UDI) on parts and labels in compliance with the requirements in the new UK Medical Devices Regulations or the CRC;
- comply with the post-market surveillance (PMS) requirements in the UK Medical Devices Regulations 2002; and
- register with the MHRA.
The regulatory review of these devices would depend on their risk category, as follows:
* The categories are broad descriptions for illustration purposes only. There might be excluded devices for certain CRCs. It will be necessary to check for each device which regulatory review is required.
** These devices have been added to international reliance following the consultation response.
The proposed framework would provide a certificate of international reliance that can then be used to register with the MHRA and gain access to the GB market, but would not provide a UKCA marking or UKCA certification.
In practice, this means that for GB market access, a US manufacturer will be able to either:
- go through international reliance scheme which involves a lighter touch review, avoiding the burden of full double certification, or
- subject to a successful consultation on indefinite CE-mark recognition, consider getting a CE-mark to cover both EU and GB markets.
The decision will depend on the manufacturer’s plans in relation to geographical expansion (whether they wish to market just in the GB, or also in the EU), as well as on cost. If the US manufacturer plans to market in the EU as well as GB, CE-mark may be a better choice, provided that the future consultation confirms the indefinite recognition of the CE-mark.
In vitro diagnostic devices
To gain access to the GB market, depending on the classification of the IVD device, manufacturers must complete either a self-declaration or conformity assessment undertaken by a UK approved body.
Under the current MDR 2002, IVD devices are classified using a list-based classification system based on their impact on patient and public health.
The proposed new system will shift from the existing list-based classification to a risk-based framework, aligning more closely with the EU legislation and the International Medical Device Regulators Forum (IMDRF) principles.
In summary, the following conformity assessment procedure is proposed:
- Class A IVD devices: UKCA self-declaration of conformity
- Class B IVD devices: UKCA self-declaration of conformity + Quality Management System (QMS) certification
- Class C IVD devices: UKCA conformity assessment by an approved body
- Class D IVD devices: UKCA conformity assessment by an approved body + Batch release testing + common specification requirements.
The above proposal amends the conformity route to market for Class B IVD devices.
Under the proposed classification system, Class B devices would require a UKCA self-declaration of conformity and Quality Management System (QMS) certification. Therefore, the conformity assessment by an approved body would not be needed. This is different to the approach under the EU IVDR and may be helpful for manufacturers of Class B diagnostic devices who are looking to access the GB market.
CE marked IVDs will continue to have a pathway to the GB market at least until 2028/2030 and as detailed above, the UK government proposes to consult further in due course, on its approach to CE marked devices after these dates.
Why it matters
The proposed changes will decrease the regulatory burden and will allow for a simpler process for Class B diagnostics which may make UKCA certification attractive.
What’s next
Amendments relating to international reliance and IVD devices will be taken forward in the ‘Pre-Market’ legislation currently being developed, which will be subject to World Trade Organization (WTO) notification requirements and brought into force as soon as Parliamentary time allows thereafter. The UK government expects to publish the draft legislation on the WTO website later this year.
Separately, the UK government will prepare a consultation regarding the approach for CE marked medical devices and will provide an update on this in due course. In the meantime, CE marked devices continue to be accepted in Great Britain until June 2028 or June 2030 (depending on the specific device).
[View source.]
