Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
Read and act on the official notice on GOV.UK
In plain English, for the pharmacy team
Why is this relevant to community pharmacy
This is about medical devices that may be supplied or held by pharmacies, such as swabs, dressings, scalpels and blood collection or infusion sets. The Medicines and Healthcare products Regulatory Agency (MHRA) says they do not have valid UK Conformity Assessed (UKCA) or CE conformity marking or certification, so their safety, sterility and performance cannot be fully guaranteed. It matters to any pharmacy team that orders, stores, supplies or uses these items.
What needs to be done
- Check whether your pharmacy holds, uses or supplies any of the devices listed in the notice.
- Immediately stop using and supplying any identified product, and quarantine all remaining stock.
- Pharmacists: keep the affected devices aside pending further advice from the MHRA.
- Pharmacists: alert the MHRA that you have an affected device by emailing devices.compliance@mhra.gov.uk and quoting Device Safety Information (DSI)/2026/007.
- Replace with alternative compliant products.
- Report any suspected or actual adverse incidents involving these devices through the correct regional route: Yellow Card in England and Wales, IRIC and local incident reporting in Scotland, or Yellow Card website in Northern Ireland.
- Read and act on the official GOV.UK notice.
Pharmshark summary, checked and approved by Chris Dotchin on 2 Nov 2026. It is not the official notice: always read and act on the GOV.UK notice.
How this summary was written
An AI tool drafted it from the MHRA's own notice and nothing else. A second check compared every line with the notice. Pharmshark's clinical lead then read it against the notice, edited it where needed and approved it. If the MHRA changes the notice, this summary is taken down until it has been checked again.
The MHRA's summary
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 Regulation (EU) 2017/745 (EU MDR).
MHRA's audience tags: Dentistry, Emergency medicine, General practice, General surgery, Haematology oncology, Infection prevention, Pathology, Pharmacy, Theatre practitioners