Government response to medical device regulation consultation
THE Government has published its response to a consultation on medical device regulation.
The Medicines and Healthcare products Regulatory Agency (MHRA) launched the consultation in September 2021.
IPEM's Engineering Policy and Standards Panel led on submitting a response to the consultation and the Government has now published its response to it.
IPEM Fellow Justin McCarthy, one of the many members who contributed their expertise to the IPEM response, said the Government response did not contradict anything contained in IPEM’s current Best Practice Guide on medical devices.
Writing on IPEM’s Communities of Interest, he said it appears from the Government response there will be a formal 'in-house exemption' from full conformity assessment and UKCA marking for devices made and used within the same health institution, provided certain conditions are met.
Mr McCarthy said these conditions are broadly in-line with those which would have had to be met had the EU MDR been retained post-Brexit - meeting relevant essential requirements, developing and manufacturing in-house devices under a QMS , documentation retention, adverse incident reporting and so on.
He said the Government’s response indicates there will be a requirement to register in-house devices with the MHRA and to register clinical investigations and performance studies.
Mr McCarthy added there was also a hint in the response at the possibility of a more open approach to providing in-house devices from one Health Institution to another, provided this is not for commercial or profitable purposes, but this needs to be clarified.