Recently we have seen updates from the MHRA (medicines and healthcare regulations authority) appointing new notified bodies for the MDR (medical device regulation), supporting faster certification of safe and effective medical devices for healthcare professionals and the public.
These include:
– TÜV SÜD
– Intertek
– TÜV Rheinland
TÜV Rheinland UK has also been designated to assess and certify general medical devices as well as in-vitro diagnostics (IVD’s).
This almost doubles the number of notified bodies meaning more availability for appointments of bodies for product registrations.
TÜV SÜD becoming a UKAB (UK approved body) also means they can simultaneously provide UKCA and CE marking certifications for medical device manufacturers, this can and will reduce the time it takes to market across Europe and hopefully also save money.
If you are looking to get in a position where your devices are compliant and ready for submission from a regulatory and/or Quality standpoint, you can see our Regulatory Submission Support page here, which includes UKCA marking, and our Quality management systems support page here
You can see the full publication on the UK GOV website here
