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Published 29 abril 2020
The Medicines & Healthcare products Regulatory Agency (MHRA) is continuing to update its guidance in response to the coronavirus pandemic and has made a number of decisions which affect life science companies and businesses in the health and social care sphere. Big changes include the relaxation of regulatory requirements for medical devices and flexibility around protocols for clinical trials, with the aim being to ensure a continued supply of products and resources needed to fight the coronavirus pandemic. This summary highlights the key updates in the regulation of medical devices, clinical trials and COVID-19 testing.
The European Commission has adopted a proposal to postpone the date of application of the Medical Devices Regulation for one year until 26 May 2021 to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. The delay to MDR implementation will impact the sector favourably and remove the need for the MHRA to enforce regulations at this time when there are other priorities.
The MHRA has introduced a fast track approval process for medical devices. It requires an application to be made setting out why the device should be exempt. You will be expected to have evidence that the device performs as intended, for example, performance data such as bench testing. In these exceptional times, the MHRA may authorise the supply of non-CE marked devices in the interest of the protection of health.
The MHRA has released guidance on ventilator use in hospitals during the current COVID-19 pandemic based on what is considered “minimally acceptable” by medical professionals and medical device regulators. The advice relates specifically to ventilators used in the initial care of patients requiring urgent ventilation due to COVID-19. The guidance states that ventilators:
• Must have at least 1, optionally 2 modes of ventilation, one of which must be Continuous Mandatory Ventilation (CMV).• The CMV mode must either have:
i. (Ideally) Pressure Regulated Volume Control; orii. Pressure controlled ventilation (PCV); oriii. (Minimally) a Volume Controlled Ventilation (VCV).
The rationale behind the new specifications is that respiratory secretions in coronavirus patients are much more copious than in ‘normal’ critical care pneumonia, meaning more frequent suctioning is required. Additionally, the duration of intubation is longer. This impacts the number of different types of ventilators needed and with a higher requirement on ventilators that are capable of supported spontaneous breathing modes.
More on the ventilator specifications and guidance can be found here.
In line with its mission to scale-up COVID-19 testing, the DHSC is seeking proposals in support of reliable and accurate antibody testing that are scalable, resilient and scientifically robust. The MHRA has issued specifications to assist manufacturers to design and deliver tests that might be useful. A test kit with lower specifications than those listed is likely to provide no clinical benefit and might lead to increased harm, which the MHRA say would be unacceptable.
Some manufacturers are selling products for the diagnosis of coronavirus in community settings, such as pharmacies. The current view of Public Health England is that use of these products is not advised. MHRA confirms that there are no CE-marked tests for home use, and it is illegal to supply such products.
Laboratories that wish to partner with an NHS trust to contribute to the COVID-19 Testing Programme will need to meet certain criteria including:
• Sample reception area for accepting and logging samples adhering to national infection control procedures;• Sample tracking capability;• Automated result analysis systems in line with national policy;• Utilising equipment and test kits that are validated by PHE/NHSE; and• Specialist workforce available e.g. PhD students or Postdocs with relevant experience that can work in rotas according to the needs of the NHS.
The MHRA has said that it will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time, recognising that clinical trial resource may be absent or redeployed from research activities and regulatory affairs towards front-line care.
Any new submissions for clinical investigations that will have a direct impact on the COVID-19 emergency will be processed through an expedited review. Protocol deviations as a result of COVID-19 do not need to be notified to MHRA; however good records of these deviations should be maintained.
More than 80 medicines used to treat patients in intensive care units have been banned from parallel export from the UK. The parallel export ban will help ensure there is an uninterrupted supply of medicines for NHS hospitals treating coronavirus patients. The new restrictions cover crucial medicines such as:
• Adrenaline• Insulin• Paracetamol• Morphine
Companies that parallel export a medicine on the ban list may face tough enforcement action from the MHRA and risk having their trading licence revoked for serious breaches.
PPE is crucial for frontline workers to the fight against coronavirus. Current guidance from the Department of Health and Social Care (DHSC) states that any clinician or care professional working within two metres of a confirmed or suspected Covid-19 patient should wear an apron, gloves, a surgical mask and eye protection. Beyond health and social care workers, current clinical evidence says there is not a widespread benefit from wearing PPE. Instead, the best way to protect yourself and others is to regularly wash your hands and to keep at least two metres between you and other people whenever you leave your house.
New PPE regulations from the Office for Product Safety & Standards state that for a limited time, where COVID-19 related PPE is being purchased by the Government/ NHS bodies for use by healthcare workers it does not need to be conformity assessed providing it has been manufactured either in line with a relevant European Standard, in accordance with a standard referenced in the WHO guidelines or to an alternative technical solution that delivers adequate safety. Products procured in this way must be approved by the Market Surveillance Authority.
The government is inviting businesses who can support the response to coronavirus through providing, amongst other things, medical testing equipment, medical equipment design and manufacturing equipment, to contact them here.
Any guidance contained in this update is subject to rapid change as the science relating to coronavirus develops. We will continue to publish updates on the legal changes presented by COVID-19, which are available on our website.
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