In the UK, manufacturers of a medical device must have their products certified to demonstrate it meets certain regulatory requirements and quality standards. Historically, this has been the CE mark (European conformity mark), but a new UKCA mark (UK Conformity Assessed) has now been introduced.
Certification marks can only be granted by Approved Bodies. The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed DEKRA as the first new Approved Body since the introduction of the UKCA mark. This means that DEKRA joins BSI Assurance UK, SGS United Kingdom and UL International in being qualified to grant medical devices with the UKCA certification, potentially increasing the capacity of the UK to process necessary assessments.
Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer said:
- “This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health”
- “Approved Bodies play a critical role in the supply of medical devices and expanding capacity is vital to the successful development of the UK’s medical device regulatory regime. This has been a significant piece of work and our teams have worked extremely hard to get to this stage”.