New Rules on ventilators
On Friday 20 March 2020, the Medicines and Healthcare Regulatory Authority (MHRA) issued guidance on ‘Rapidly manufactured ventilator system specifications’ to help combat the COVID-19 pandemic. The guidance confirms that such ventilators do not need to go through the process to be “CE Marked” as medical devices in the ordinary way.
The specifications set out the new requirements for ventilators, which are less demanding than current manufacturing requirements, and represent the ‘minimally acceptable’ performance required of a ventilator as set out by clinicians. This change has been spearheaded by a nationwide dearth in ventilators needed to combat the COVID-19 pandemic.
The devices are strictly for patients most likely to benefit from ventilators, who are suffering with Acute Respiratory Distress Syndrome (ARDS) induced by COVID-19. Any ventilator failing to comply with the new lowest standard will not be used, as clinicians agree that they may be more harmful than beneficial to a patient.
This guidance explicitly states that this is a temporary measure:
“When the current emergency has passed these devices will NOT be usable for routine care unless they have been CE marked through the Medical Device Regulations. The device must display a prominent indelible label to this effect.”
This temporary change will not be a long-term route for ventilator manufacturers to bring lower specification ventilators to market. The guidance confirms that all ventilators manufactured via this route must state that the ventilator is NOT CE marked.
In normal circumstances, Class IIa and above medical devices such as ventilators must bear a CE mark before being placed on the market. These requirements are set out in Regulation 10 Medical Device Regulations 2002 (MDR 2002). This could well take up to two years in the current climate.
In light of the current crisis the MHRA will approve ventilators through the ‘Exceptional use of non-CE marked devices’ route. This route allows for the use of non-CE marked devices in two instances:
- A manufacturer applies to supply a medical device that does not comply with law, in order to protect a patient’s life and there is no viable alternative.
This route is commonly used to treat a specific patient, but is not appropriate for mass production of ventilators.t
- The MHRA authorises a manufacturer to supply a non-compliant device in the interest of public health, under Regulation 12(5) MDR 2002.
Regulations 8 and 10 shall not apply 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.
It remains to be seen exactly how the logistics of Regulation 12(5) MDR 2002 will play out, but these moves by the MHRA will certainly see more ventilators reaching hospitals in the near future.