UK Allows Non-CE-Marked Devices On Market Under Exceptional Use Route
The UK government has launched an initiative to get non-medtech manufacturers involved in the production of ventilators. But it looks like they will be scrapped after the emergency has passed.
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With concerns that ventilation of COVID-19 patients is less effective than for non-infected patients, the UK’s MHRA has issued updated advice.
With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.
How to quickly get non-CE-marked medical device onto the UK market.