The MHRA have increased their capacity to process conformity assessments for medical devices with the addition of DEKRA Certification Ltd to their existing three UK approved bodies. This will ensure that safe and effective devices can reach the public faster.
DEKRA has become 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 can now undertake assessments for general medical devices (known as Part II designation).
Approved bodies are organisations which the MHRA have deemed suitable to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002.
If an assessment is passed, the approved body will then issue certification allowing manufacturers to place UKCA markings on their products before they are placed on the market in England, Wales and Scotland.
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.
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”.
