Medical devices on the European market have long been required to display a Conformitè Europëenne (CE) mark, a symbol of conformance, on the labelling to be deemed safe for use. However, now that the United Kingdom (UK) has left the European Union (EU), the regulatory requirements for conformance of medical devices will become more complicated. On July 1st, 2023, EU notified bodies will no longer be recognized in the UK. Likewise, UK notified bodies will no longer be recognized by the EU.
Read on to learn how Britain’s exit from the EU may affect the regulation and conformity compliance of your medical devices.
After Britain’s exit from the EU, they established separate regulatory standards and their own conformance mark, UKCA (United Kingdom Conformance Assessed). After June 30th, 2023, medical devices marketed in the UK (including England, Wales, and Scotland) will no longer be recognizing the EU CE mark. The UKCA mark will be the only recognized mark to show conformity to regulatory standards in the United Kingdom.
Medical device manufacturers outside of the UK will need to work with a UK Responsible Person (formerly a Notified Body) to register and evaluate the device on their behalf as EU Notified Bodies will no longer be recognized by the UK. Information for the UK Responsible Person, including name and address, must be visibly displayed on medical product labelling containing a UKCA mark.
Required mark(s): UKCA
Unaccepted mark(s): CE and UKNI
Northern Ireland will continue to require the EU CE mark after July 1st, 2023 and must meet the established EU conformity requirements. Northern Ireland will continue to accept evaluations from both EU and UK Notified Bodies. However, the required markings will change depending on the jurisdiction of the evaluating party. If a medical device is evaluated by an EU Notified Body, only the EU CE mark will be required. If the device is evaluated by a UK Responsible Person, an additional UKNI mark will be required. The UKCA mark will not be accepted in Northern Ireland.
Required mark(s): CE
Accepted mark(s): CE and UKNI displayed together
Unaccepted mark(s): UKCA
After June 30th, 2023, medical devices in the EU market will still require a CE mark. However, beginning July 1st, 2023, notified bodies located in the UK will no longer be recognized by the EU. Medical devices on the European market will need to be evaluated by an EU Notified Body. Medical devices that are intended for both the European and UK markets will need to display both the CE and UKCA marks. Medical products bearing the dual CE and UKCA marks will be accepted as long as both marks are clearly visible. However, products bearing the dual CE and UKNI marks will not be accepted.
Required mark(s): CE
Accepted mark(s): CE and UKCA displayed together
Unaccepted mark(s): UKNI
Please note QTS and Cretex Medical are not regulatory specialists. This information is meant to inform about the new regulatory requirements and their potential impacts.
Ask your regulatory specialist or Notified Body if and how these changes will affect you. Your regulatory specialist can work with you to ensure your medical devices will continue to conform to the regulatory standards required by your target market(s).
The information above was collected on June 28, 2022, from the following sources:
Regulating medical devices in the UK – gov.UK
UKCA Marking and CE certification| BSI America (bsigroup.com)