UK companies interested in producing ventilators and other critical equipment may benefit from regulatory exemptions and use government product specifications.
On 16 March 2020, Prime Minister Boris Johnson called on the UK’s leading manufacturing businesses to help the UK step up production of vital medical equipment to combat the COVID-19 crisis.[i]
With no proven COVID-19 treatment or vaccine to date, ventilators are a critical piece of equipment to help treat patients with acute symptoms of the disease. The UK industry has responded to the government’s call, with a number of companies in the aerospace and automotive sectors reportedly working on plans to lend capacity to manufacture ventilators. Meanwhile, a number of newly designed ventilators and breathing aids have reportedly gained regulatory approval and are either undergoing trials or are already subject to orders from the UK government.
Ventilators are regulated as medical devices and, in the ordinary course, would require a conformity assessment by a notified body and CE marking before being placed on the market or put into service. Conformity assessments by notified bodies involve detailed reviews of technical documentation and the manufacturer’s quality management system. However, given the urgency of the need for ventilators, along with the backlog for notified body assessments as a result of the forthcoming EU MDR[i] and IVDR[ii], the conduct of these time-consuming assessments is not feasible to meet current urgent demand for certain medical devices.
Regulation 12(5) of the current Medical Devices Regulations 2002[iii] provides for exemptions to the CE marking requirements and the obligation to comply with essential requirements where:
“…following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.”
A similar exemption exists under Regulation 39 for in vitro diagnostic medical devices that will capture COVID-19 test kits.
Details on how to apply for Department of Health and Social Care (DHSC) approval and Medicines and Healthcare Products Regulatory Authority (MHRA) authorisation to sell a non-CE marked device in the interest of the protection of health are available here.
The MHRA has published minimum specifications for clinically acceptable rapidly manufactured ventilator systems (RMVSs) to be used in UK hospitals during the COVID-19 pandemic (the Specifications). These Specifications are for devices that are most likely to confer therapeutic benefit on a patient suffering with acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2, used in the initial care of patients requiring urgent ventilation. The Specifications outline what is stated to be “the consensus of what is ‘minimally acceptable’ performance in the opinion of anaesthesia and intensive care medicine professionals and medical device regulators”. The Specifications acknowledge that the ventilators would be used for short-term stabilisation for a few hours, but this may be extended up to one day as the bare minimum, but ideally would also be able to function for a number of days until more advanced ventilator support becomes necessary.
Other noteworthy requirements set out by the Specifications, which recognise the exigencies of the present crisis include that the ventilators:
- Must be reliable
- Must be intuitive to use for qualified medical personnel, even though these may not be specialists in ventilator use
- Must not require more than 30 minutes training for a doctor with some experience of ventilator use
- Must not be excessively cumbersome
- Must be made from materials and parts readily available in the UK supply chain (anticipating increasing global restrictions on freight movement)
The Specifications recognise that full demonstration of compliance with applicable standards is unrealistic in the current urgent time frame, but nevertheless the ventilators must meet essential safety standards and pass usability testing by a user wearing complex protective clothing.
The Specifications state that these RMVS devices will be approved via the “Exceptional use of non-CE marked medical devices” route (see above) and will not be usable for routine care once the current emergency has passed and must be CE-marked in the normal course if they are to continue to be placed on the market. The devices are required to display a prominent indelible label to this effect as well as complying with other specific labelling requirements.
Note that the British Standards Institute (BSI) has made the BSI standards on ventilators referred to in the Specifications freely available here.
In addition to ventilators, the MHRA has made announcements regarding other COVID-19 related devices:
- Similar specifications have been issued for less invasive Continuous Positive Airway Pressure (CPAP) devices. The relevant specifications are available here. Companies intending to manufacture ventilators or CPAPs should first send a derogation request to the DHSC here. Following approval, the manufacturer should apply for expedited approval from the MHRA here. Further information on applications is available here.
- Companies intending to manufacture other devices, such as surgical masks or surgical gloves will not require DHSC approval and can apply directly to the MHRA here.
- On 2 April 2020, the MHRA stated that it was no longer accepting applications to place test kits on the market. All enquiries regarding COVID-19 test kits should be submitted here.
Be Aware of Ongoing Developments
Companies operating in this fast-changing environment should closely monitor developments and remember that public safety will remain paramount, with the MHRA announcing an investigation into “bogus medical products” claiming to treat or prevent COVID-19 on 4 April 2020.[iv]
For the MHRA’s guidance on COVID-19, see here.
Latham & Watkins will continue to monitor and report back on developments related to the impact of COVID-19 on the life sciences sector.
[i] Regulation (EU) 2017/745.
[ii] Regulation (EU) 2017/746.