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). While the MHRA has not identified a specific defect or safety concern associated with these products, they do not meet the regulatory requirements for supply on the UK market, meaning assurance regarding their safety, sterility and performance cannot be fully guaranteed. The affected devices may be used in a variety of clinical settings, including blood collection and infusion, surgical procedures, biopsy procedures, wound management and skin preparation/ disinfection.
- review whether your organisation holds, uses or supplies any of the devices listed in this DSI
- immediately stop using and supplying any identified product(s) and quarantine all remaining stock
- identify and use alternative compliant products
- retain affected devices pending further advice from the MHRA
- alert the MHRA that you are in possession of an affected device via devices.compliance@mhra.gov.uk quoting the DSI reference number (DSI/2026/007)
- providers should ensure all relevant members of staff receive this Device Safety Information (DSI) and that they understand the problem and actions to be taken
- healthcare professionals should report incidents:
- there is no advice for healthcare professionals to provide to patients regarding this DSI
- identify any affected devices within your possession or control
- cease further supply of affected devices
- notify the MHRA immediately via devices.compliance@mhra.gov.uk if you think you have received, supplied or distributed any affected devices, and provide details of any onward distribution where known and quote the DSI reference number (DSI/2026/007)
- assist the MHRA with traceability activities where requested
- maintain records of customers supplied with affected devices
- inform customers who may have received affected stock
The MHRA has become aware of a number of medical devices being supplied in the UK market which do not comply with the applicable UK medical device regulatory requirements. These devices and their manufacturers are listed above.
The MHRA has not identified a specific device defect, performance issue or safety signal associated with these products. However, without legitimate UKCA or CE device certification required for supply on the UK market, assurance regarding conformity assessment, quality management systems, safety, sterility and performance cannot be fully guaranteed.
- NHS Wales
- NI Health Estates Directorate
- Medical Device Safety Officers (MDSOs)
Annex
Annex 1: Images of the Devices Identified
Meditech Devices Pvt. Ltd. Bone Marrow Biopsy Needle
Bipson Surgical Private Ltd Gauze Swab Sterile
Precision Coatings (P) Ltd Medi Grip Adhesive Bandage (Antiseptic)
Romsons Group Private Ltd Alco Swab
Niraj Industries Ltd Technocut Scalpel
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗