There have been two recent developments in the United Kingdom in the light of the new Medical Devices Regulations: One already implemented on post-market surveillance, and one on the future UK MDR, including the international reliance program.
New Post-Market Surveillance (PMS) requirements
The Post Market Surveillance Requirements Regulation 2024 has introduced significant changes to the PMS and vigilance framework since its implementation on 16 June 2025[1],[2].
Key changes include:
- Manufacturers must maintain a written PMS plan detailing how they will monitor device performance and safety throughout its lifecycle.
- Change to the serious incident reporting timeline, to be reported within 15 days instead of 30 days.
- Periodic Safety Update Reports (PSURs) are now required for higher-risk devices (Class IIa, IIb, III, and certain IVDs), with reporting frequency based on risk classification. They must be provided to the Medicines & Healthcare products Regulatory Agency (MHRA) on request within three working days.
- For other devices (Class I), a PMS report is required, with updates at least every three years.
- For incidents that do not meet the threshold for individual reporting, manufacturers must submit trend reports.
The changes require certain actions by device manufacturers, including:
- The requirements must be implemented by manufacturers and included in their Quality Management Systems (QMS) –if they exist.
- As these requirements are similar to the EU MDR/IVDR (Medical Devices Regulations / In Vitro Diagnostic Regulation)[3], existing PMS systems can be leveraged, but reference to UK regulations must be included.
Future UK MDR
In January 2025, the MHRA held a consultation in relation to IVDs and the international reliance scheme. The consultation received 287 responses from various stakeholders (manufacturers, trade associations, individuals). The government presented its response on three topics:[4]
- International reliance
Once the new UK MDR amendments are implemented, manufacturers will be able to leverage existing assessments or registration for easier access to the Great Britain (GB) market.
To be eligible, the medical device must:
- Have marketing authorization in Australia, Canada, or the US (also referred as Comparable Regulator Countries or CRC) and a certified QMS.
- Fall in scope of the UK MDR.
- Be classified according to the UK MDR.
- Have English labeling and packaging, and have an Instruction for Use (IFU) and implant card, where applicable.
- Comply with other applicable GB requirements, such as machinery, electronics compatibility, unit of measurement, labeling of materials of concern.
- Have a UK Responsible Person named on the labeling, packaging or IFU.
- Have UDI on parts and labels.
- Comply with UK PMS requirements.
- Register with MHRA.
Different routes will be available, depending on device type and class:
| Route | Eligible devices | UK Approved body review |
| 1 | Low risk devices
– Class I MD (other than Im/s) – Class A IVD (non-sterile) |
Not required.
A self-declaration for an appropriate QMS must be provided to the MHRA during registration |
| 3 | – Class Is/m, IIa, IIb, III MDs
– sterile Class A IVD devices – Class B, C IVD devices
Unless listed under route 4 |
The review by a UK approved body includes confirmation of the following:
– Marketing authorization – GB classification – Implant card and patient leaflet compliance with GB requirements – Availability of information related to reuse (cleaning, disinfection, packaging, sterilization) of reusable devices – compatibility with GB electrical requirements (for active devices) – For software as a medical device, review information that demonstrates there are no differences between the CRC and GB that adversely impact the safety or efficacy of the device and the appropriateness of any pre-determined change control plans
The approved body will also review the PMS plan and available PMS data. |
| 4 | – Class IIa, IIb and III (including implantable and software) that comply with 510(k) legislation in the US[5]
– Medical devices that incorporate an ancillary medicinal substance – Class D IVD devices
|
The review by a UK approved body includes:
– Review as per route 3 – Confirmation that the rationale for equivalence to a reference device for 510(k) devices meets the UK MDR requirements – Obtaining an opinion on the quality and safety of any ancillary medicinal substance incorporated into the device – Confirmation that class D IVDs meet batch test release requirements. |
An additional route (route 2) was described in the consultation for CE marked devices. However, the government decided not to include these devices and will organize a new consultation this year, proposing either indefinite recognition of CE marked devices or inclusion in the international reliance routes described above. In the meantime, all CE marked medical devices benefit from recognition and direct access to the GB market until 30 June 2030 (if compliant to EU MDR/IVDR).
The international reliance will remove the need for a full UKCA marking procedure[6] for eligible devices, saving time and money for their manufacturers.
- UKCA marking
Once separate requirements for Unique Device Identification are in place (the database being operational and the transition period having been concluded), the application of UKCA marking on the labeling of devices that have been through the UK conformity assessment process will become voluntary.
- IVD conformity assessment routes
The conformity assessment procedures on IVDs will be as follows:
- Non-sterile Class A IVD devices: UKCA self-declaration of conformity.
- Non-sterile Class B IVD devices: UKCA self-declaration of conformity plus QMS certification.
- Sterile Class A and B IVD devices: Class A or Class B route plus UKCA conformity assessment by an approved body for sterility requirements only.
- Class C IVD devices: UKCA conformity assessment by an approved body.
- Class D IVD devices: UKCA conformity assessment by an approved body plus batch release testing and common specification requirements.
The main difference with the EU IVDR is for non-sterile Class B IVDs, which will only require UKCA self-assessment of conformity plus QMS certification. QMS certification must be to ISO 13485[7] and issued by a United Kingdom Accreditation Service (UKAS) accredited body or an International Accreditation Forum (IAF) accredited body from Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam)[8].
A transition period of five years after the publication of the regulation is expected, and further consultation will be held regarding CE marked IVDs (as described above).
Next steps
The proposed international reliance, UDI, and IVD conformity assessment routes will be included in the UK MDR “Pre-market” amendments that are expected to be submitted to the Word Trade Organization (WTO) later this year and approved by the UK Parliament as soon as possible thereafter. The transition period is expected to be three years for medical devices and five years for IVDs, for devices with valid certification/declaration of conformity.
About the author:
Audrey Toulemonde, is Associate Director, Medtech Services, at PharmaLex. She has over ten-year experience in all aspects of regulatory affairs, from product development to creation of technical documentation and lifecycle management for medical devices or drug-device combination in Europe and the UK.
[1] Medical devices: post-market surveillance requirements, Gov.UK., Jan 2025. https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements
[2] Vigilance reporting requirements, Gov.UK, Updated June 2025. Vigilance reporting requirements – GOV.UK
[3] Medical Devices regulations, European Commission. https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
[4] Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, Gov.UK, Nov 2024. https://www.gov.uk/government/consultations/consultation-on-medical-devices-regulations-routes-to-market-and-in-vitro-diagnostic-devices
[5] Premarket Notification 510(k), FDA. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
[6] Regulating Medical Devices in the UK, Gov.uk https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
[7] ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes. https://www.iso.org/standard/59752.html
[8] The Comprehensive and Progressive Agreement for Trans-Pacific Partnership, House of Commons Library. https://researchbriefings.files.parliament.uk/documents/CBP-9121/CBP-9121.pdf
