The Medicines and Healthcare products Regulatory Agency (MHRA) is clearly trying to help with a loosening of some rules. On 20th March it issued its specification for "Rapidly Manufactured Ventilator System".
"This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators."
Yesterday it published "Exemptions from devices regulations", sub-headed "Fast-track approval of medical devices during COVID-19 outbreak". Peer review and full clinical trials may not be necessary; if the manufacturer says it complies, that'll be fine.
In theory, UK medical device regulation is line with Europe legislation, and should still be, because we're in the year of transition. And tougher new EU rules - MDR - come into force in May this year, tightening up on compliance and notification. Various pieces of government guidance during the Brexit negotiations have been withdrawn, on 31st January 2020 and on 13th March 2020.
Existing EU rules require manufacturers to win the CE mark for their product. On the left, a simplified view of the process.Back in November 2018, Dr Ian Hudson, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), announced his intended departure in September 2019. Dr June Raine became interim Chief Executive from 20 September 2019.
I can't find any standalone UK specification for ventilators before the 'rapidly-manufactured' document of 20th March - we relied on Europe.
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