With UK prime minister Boris Johnson calling on non-specialist firms from a variety of industries to weigh in and help solve the country’s Covid-19 ventilator shortage, regulation may be one of the biggest obstacles standing in their way.
The government’s Department of Health and Social Care (DHSC) recently revealed the NHS has about 5,000 adult ventilator machines at its disposal, and an additional 900 of these devices for children.
How many ventilators are needed for Covid-19 patients – and regulations obstructing manufacturing expansion
It is estimated as many as 20,000 extra ventilators could be required to treat infected patients during the coronavirus pandemic.
Because of this, a number of manufacturers with bases in the UK – including Ford, Honda, Rolls-Royce and JCB – are reportedly turning their attentions towards helping to build these life-saving pieces of equipment.
As firms attempt to collaborate amid a growing public health crisis, they may have to adhere to the same rules and regulations as the rest of the medical device sector.
And, as outgoing Medical Device Developments editor Emma Green notes, it is by no means an easy process for manufacturers to navigate their way through.
“It’s quite a closed industry”, she says. “They are typically not looking at what other industries are doing, so it tends to be quite insular.
“In light of the complexity and sheer volume of regulation, the industry is relatively slow-moving compared to other sectors. Products typically take months and years to get to market, rather than weeks.
“Given existing legislative requirements – as well as the complexities involved in obtaining relevant components and tooling – there currently aren’t clear pathways to move forward in the way the government has suggested.”
How UK medical devices regulation works
Medical devices in countries within the European Union – which still includes the UK during the Brexit transition period – are governed by EU legislation.
The ‘competent authority’ on medical devices, designated by the EU to oversee medical devices in the UK, is the Medicines and Healthcare products Regulatory Agency (MHRA), which is also part of DHSC.
All new devices must meet MHRA standards to ensure they work properly and can be used safely.
The design and manufacturing of medical devices requires MHRA approval, and the regulatory body can issue recalls if they are found to be unfit for their intended purpose, or unsafe.
However, while the MHRA is responsible for enforcing standards, manufacturers can have their devices tested and certified by one of three independent ‘notified bodies’ in the UK – the most notable of which is the BSI (British Standards Institute) Group.
Companies wishing to sell these devices also have to register with the MHRA.
EU regulations also require devices to obtain a CE marking, which can be obtained from notified bodies and indicates they conform to the required health, safety and environmental standards across Europe.
Updated guidelines for countries in the EU were passed into legislation in May 2017, introducing increased safety measures and stricter regulation around the clinical performance of devices.
After an initial implementation period of three years, these guidelines were set to come into use on 26 May 2020, and be applied to all devices already in use – in addition to any newly-produced ones.
However, the coronavirus outbreak and its impact on EU member states like the UK, Germany, Italy and Spain has led to this deadline being postponed by one year.
As things stand, the current EU Medical Device Directive (MDD), and the Active Implantable Medical Devices Directive (AIMDD), will be repealed and replaced by new legislations named the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) in May 2021.
EU restrictions on medical devices sold or manufactured in the UK will still apply after the country completes its transition period, and exits the European Union, at the end of 2020 – except in the event of a ‘no-deal Brexit’.
In this instance, the UK’s current participation in the EU’s regulatory system for medical devices would end, and the MHRA would take on full responsibility for the UK market.
UK ventilator regulation explained
In the UK, medical devices are also given a classification depending on the level of risk associated with them – the strictest controls are placed upon products with the highest risk.
These include Class I devices, which are considered to be low risk, Class IIa and IIb devices, which are low-to-medium and medium-to-high risk respectively, and Class III devices, which are associated with the highest level of risk.
These classifications are based on a number of factors – including the intended purpose of the device; how long it’s intended to be in use for; and whether or not it is invasive, implantable or contains a medicinal substance.
As a Class IIb device, ventilators require clinical trials before they can be placed on the commercial market.
In order to gain a CE marking, developers must also carry out – and provide proof of – extensive quality assurance tests and examinations to ensure they conform to EU guidelines.
These extensive regulations are one of the main reasons why ventilators and other Class II devices can take months, and sometimes years, to go from being designed to reaching the commercial market.
Challenges presented by regulation
The coronavirus pandemic has led to talk of many manufacturers that don’t traditionally work on medical devices lending a hand to alleviate ventilator shortages.
One of the biggest obstacles facing these companies is the lengthy time frame associated with producing Class II devices from scratch, and the impracticalities of carrying out clinical trials under current conditions.
The fact that non-medical device manufacturers will not have a licence from the MHRA to produce these machines is also a problem in itself.
Even if traditional, licensed medical manufacturers subcontract their production to other sites, resulting devices will still need to undergo extensive testing in line with MHRA regulation.
The regulatory body would also still need to “sign off” on any device built on a new site as well.
To get around this, Green says many of these companies will have to use established manufacturing processes to build ventilators using existing designs.
However, this may present a new challenge, with reports suggesting it could take weeks, or even months, for non-medical manufacturing companies to ensure their production facilities are suitable for making ventilators.
Green believes another issue arising from the ventilator shortage is actually sourcing the parts required to build one.
These individual components come from all over the world – and the fact this has to be done within a limited time frame only increases the challenge manufacturers are facing.
