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Product safety rules: what it means for health tech start-ups
How are medical devices regulated in the UK?
Updated 6 November 2026 from public records. 11 items below.
At a glance
- 11 records from the last 120 days, 5 naming health tech directly
- No consultation on this open right now
- Most active: Medicines and Healthcare products Regulatory Agency
- Latest record: 5 November 2026
The Product Regulation and Metrology Act 2025 lets government update product safety rules by regulation, including duties on online marketplaces, and decide how far to follow EU rules. Regulations under it are arriving in stages. For a company that makes or sells physical products, the duties on what it sells, and on the platforms it sells through, are both changing. The Act on legislation.gov.uk.
What it means for your start-up
Medical devices, including software, sit outside the Product Regulation and Metrology Act. They are regulated by the MHRA under the UK Medical Devices Regulations 2002, and the MHRA is reforming the rules in stages. In October 2026 the government confirmed that CE-marked devices will be accepted in Great Britain long term, with regulations to follow; devices still certified under the older EU directives face a cut-off. Getting the classification right decides how much evidence a device needs before it can be sold.
What to do now
- Confirm your device's classification under the UK rules, as it sets the evidence you need.
- Follow the MHRA's reforms, including the regulations that make CE recognition permanent and the cut-off for devices certified under the older EU directives.
- Plan your post-market surveillance, which the new rules strengthen.
Latest from government
Marked: mentions health tech directly.
- MHRA sets out approach to strengthen patient and public involvement and engagement in medicines and medical device regulation
New plan will broaden participation and make clearer how patient experience informs regulatory decisions, safety and innovation - Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the… - Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices… - MHRA advises quarantine of medical devices supplied without appropriate conformity markings
The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations or with the EU Medical Devices Regulation. - Stakeholder views on tumble dryer safety
Invitation to OPSS stakeholders to share views, data and other relevant evidence about tumble dryers supplied for use in the UK. - VAT online marketplace liability extension
This tax information and impact note is about the extension of online marketplace liability to all sales of goods where the marketplace facilitates the sale of those goods by UK businesses. - Factsheet on Extending VAT Online Marketplace Liability Rules
This factsheet provides information about the extension of online marketplace liability for VAT.
In Parliament
Marked: mentions health tech directly.
- Health Bill
Further consideration of Bill, as amended in the Public Bill Committee [Relevant documents: First Report of the Health and Social Care Committee, Health Bill 2026-27, HC 219; and oral evidence taken before the Health… - What assessment she has made of whether existing powers under the Product Regulation and Metrology Act 2025 are adequate to address product safety and supply…
Asked by Helen Maguire (LD). Electric Bicycles and Electric Scooters: Safety — The Product Regulation and Metrology Act is a matter for the Department for Business, Innovation, Science and Trade (BIST). BIST will… - What plans they have to introduce regulation about the levels of heavy metals, per- and polyfluoroalkyl substances, pesticides, plastics and toxins in period…
Asked by Baroness Bennett of Manor Castle (Green). Sanitary Products: Regulation — The UK's product safety framework requires all products to be safe, including period products. The Government's recent consultation… - What recent assessment they have made of the risk presented by the lack of specific regulation of materials used in period products; and what work they are…
Asked by Baroness Bennett of Manor Castle (Green). Sanitary Products: Regulation — The UK's product safety framework requires products to be safe, including period products. Our product safety reform consultation…
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Contains public sector information licensed under the Open Government Licence v3.0. Contains Parliamentary information licensed under the Open Parliament Licence v3.0. General information, not legal advice.