Understanding what makes medical devices compliant with UK regulations: A toolkit

The British Healthcare Trades Association (BHTA) has worked with a leading online marketplace to develop a toolkit for organisations, frontline staff, and marketplaces to understand what makes medical devices compliant in line with UK medical device regulations.

This toolkit was created because members in the BHTA First Aid & Medical Equipment (FAME) Section became concerned about seeing medical devices on marketplaces that were not marked and labelled in compliance with relevant UK medical device regulations.

The toolkit comprises of four documents that are designed to ensure medical devices are properly documented and labelled in the marketplace. This includes a detailed diagram of how medical devices should be labelled in the UK; what a manufacturer’s EC/UKCA Declaration of Conformity should look like and include; what the EC/UKCA Certification from a Notified Body looks like; and the BHTA’s explainer on medical device regulations in the UK.

Please download and view the documents below for a full picture of medical device compliancy in the UK.

1. EC/UKCA Certification (PDF opens in a new tab).
2. EC/UKCA Declaration of Conformity (PDF opens in a new tab).
3. Medical Device Labelling in the UK (PDF opens in a new tab).
4. UK medical device registration and CE/UKCA/UKNI marking (opens in new tab).