The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed its first certification body since the UK left the EU.
Dekra Certification UK Ltd has now joined the three current UK Approved Bodies, increasing the UK’s capacity to process conformity assessments for medical devices. The other certification bodies are BSI Assurance UK, SGS United Kingdom Ltd and UL International.
Dekra, based in Buskinghamshire, is the first organisation to complete the new designation process that any potential organisation must now go through in order to become approved to certify medical devices in the UK. They are now designated as a UK approved body to undertake assessments for general medical devices (known as Part II designation). The company is part of Deutscher Kraftfahrzeug-Überwachungs-Verein eV, which has revenue of over €3.5 billion and employs 47,770 people in over 60 countries on all six continents.
An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002.
With the exception of the very lowest risk devices, manufacturers must apply to a UK approved body. Only after they have UKCA certification can their products be placed on the market in England, Wales and Scotland.
“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,” said Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer. “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.”
There are a further six organisations who are currently in the assessment process and there is active engagement with several further organisations who are preparing to submit their initial submission.
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