COVID-19 Medical devices – fast track approval

The EC has published Recommendation (EU) 2020/403, which states that to address the shortage of personal protective equipment (PPE) necessary in the context of the COVID-19 outbreak, market surveillance authorities may authorise the provision of these products on the EU market for a limited period of time and while the necessary procedures are being carried out. This is even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised according to the harmonised rules.

On 25 March, the MHRA announced that it may authorise the supply of non-CE-marked devices “in the interest of the protection of health.” The UK Department of Health and Social Care (DHSC) can grant its approval so that manufacturers are able to submit their applications for exemption from the regulations to the MHRA. The DHSC may grant its approval regarding ventilators as long as they comply with the necessary specifications. For any other relevant devices such as PPE (eg, surgical face masks and examination or surgical gloves), the application can be sent directly to the MHRA. Performance data and other relevant study data is expected to be provided as evidence that the device performs as intended.

The MHRA has issued specifications for the Rapidly Manufactured Ventilator System to be used in UK hospitals during the COVID-19 outbreak. The guidance outlines 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.

A specific form for manufacturers to submit COVID-19 test kits for regulatory approval has also been created by the MHRA. The agency is developing specifications for COVID-19 tests and will make these available as soon as possible