COVID-19 Considerations for Organisations Manufacturing Ventilators
The UK Government is calling on organisations from a variety of industries to help solve the country's COVID-19 ventilator shortage. Here are some key points an organisation, especially if it is a non-medical organisation, should consider when considering manufacturing ventilators.
Regulation of Medical Devices in Europe
Medical devices in countries within the EU, including the UK during the Brexit transition period, are subject to EU legislation. Generally, EU regulations require devices to bear a CE mark, which indicates they conform to health, safety, and environmental standards. In the context of medical devices, the CE mark shows that the device conforms to the requirements of the Medical Devices Directive (MDD).
The MDD has since been superseded by the EU Medical Device Regulation 2017/745 (MDR), which came into force in May 2017, but includes a three-year transitional period. The MDR was due to fully apply in EU Member States from 26th May 2020, however, the European Commission recently confirmed that it is working on a proposal to postpone the application of the MDR for one year in light of the COVID-19 outbreak.
As a Class IIb medical device – a device classed as medium to high risk – ventilators require clinical evaluation before they can bear a CE mark and be placed on the commercial market. To gain a CE marking, developers must also carry out extensive quality assurance tests and examinations to ensure that the devices conform to EU guidelines. The extensive regulations are one of the main reasons why, in normal times, ventilators and other Class IIb medical devices can take months, and sometimes years, to go from design to the commercial market.