Today, Eurofins E&E CML Limited has been added to the approved list of UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended), bringing the total to 10 active UK approved bodies under the UK MDR 2002.
Additional UK approved bodies for medical devices include:
BSI Assurance UK Ltd (0086)
DEKRA Certification UK Ltd (8505)
INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532)
A list of the full UK approved bodies for medical devices and additional information can be found here.
For further information on how to take proactive steps for compliance with the updated standard, contact us.
The European Commission published two closely related guidance updates that directly affect how medical devices and in vitro diagnostic medical devices are qualified…