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Hill Dickinson – COVID-19: New MHRA Guidance and Processes

Hill Dickinson, an international commercial law firm and Medilink's partner, has shared advice from the MHRA following the outbreak of Covid-19 and the rapidly increasing need to provide urgent services and equipment.  The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on how manufacturers of medical devices may apply to supply test kits and non-CE marked devices for use in patient care, including ventilators. This has been produced in close consultation with the Department of Health and Social Care (DHSC) and is summarised below.

The MHRA has also published guidance on expedited applications for clinical trials relating to Covid-19, also summarised below.

COVID-19: New MHRA Guidance and Processes

Following the outbreak of Covid-19 and the rapidly increasing need to provide urgent services and equipment, the Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on how manufacturers of medical devices may apply to supply test kits and non-CE marked devices for use in patient care, including ventilators. This has been produced in close consultation with the Department of Health and Social Care (DHSC) and is summarised below.

The MHRA has also published guidance on expedited applications for clinical trials relating to Covid-19, also summarised below.

Non-CE marked devices

In exceptional circumstances such as those we now face, the MHRA may authorise manufacturers to place on the market or put into service a non-CE marked device in the interests of the protection of public health. The Medical Device Regulations 2002 allow for the fast track approval of medical devices and these powers are being utilised in an effort to address the Covid-19 pandemic.

An application must be made to the MHRA via email to devices.compliance@mhra.gov.uk with the information listed below, although the MHRA may request additional information when considering the application. It is expected that the evidence provided will demonstrate that the device performs as intended.

  • Details of the product(s) (including model name and descriptor);
  • Reasons why the product does not have a valid CE mark;
  • Clinical justification for requesting an exemption from the regulations for the product;
  • An explanation of any alternative products on the market and reasons why using these products would not be appropriate;
  • The number of product likely to be supplied under the exemption, plus an indication of how widely used the product is; and
  • The expected time to gain/re-gain CE certification.

The MHRA does not require an application to be made for the derogation of a CE-marked device where the change to intended use is limited.  It is, however, expected that a risk assessment will be undertaken and that the manufacturer will contact their Notified Body for advice first.

For some medical devices, it will be necessary to obtain approval from the DHSC first before applying to the MHRA. Only once approval has been provided should the application to the MHRA be made.  It is not overly clear which devices will require DHSC approval, although it has been confirmed that ventilators will (see below). Manufacturers of other medical devices may not require DHSC approval; the MHRA gives the examples of surgical (medical) facemasks and examination or surgical gloves.

Ventilators

The MHRA has issued a specification for rapidly manufactured ventilator systems, setting out the minimally clinically acceptable ventilator to be used in UK hospitals during the pandemic.  The guidance is available on the MHRA website, here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/876167/RMVS001_v3.1.pdf . It is based on the opinion of anaesthesia and intensive care medicine professionals and medical device regulators, and is specifically for the use of devices in the initial care of patients requiring urgent ventilation.

Amongst other requirements, it must be demonstrated that the ventilator is compliant with essential safety standards.  It is not anticipated that devices will be CE marked and approval by the MHRA will be through the “Exceptional use of non-CE marked medical devices” route, as outlined above.  DSCH approval must be obtained before the application to MHRA is made.

Covid-19 test kits

The MHRA has issued a form for manufacturers of professional use Covid-19 test kits to complete and submit to determine whether their test kit can be placed on the market.  This can be found on the MHRA’s website, here: https://www.gov.uk/government/publications/regulatory-approval-for-coronavirus-covid-19-test-kits . The manufacturer must provide information about basic performance and testing, including details of validation work, timing, detection and sample type, as well as information on commercialisation, including evidence of CE marking.  Forms must be sent via email to Devices.Regulatory@mhra.gov.uk.

Professional users should be aware that the MHRA’s review does not include a test of performance to ensure suitability.

Public Health England has advised against the use of products being sold for the diagnoses of Covid-19 infection in community settings, such as pharmacies.  Furthermore, there are currently no CE marked tests for home use: it would be illegal to supply such products.

In recent news, it has been confirmed that the government has bought 3.5 million antibody tests for Covid-19, which can be used to test whether a person has had the virus and are immune to it, rather than whether they have it.  This will allow frontline NHS workers to determine whether they can return to work.

Clinical Trials

The MHRA has confirmed that they are in a position to prioritise Covid-19 assessments and support manufacturers, researchers and other regulators since implementing procedures for rapid scientific advice, reviews and approvals.  Applications should be submitted directly to the Clinical Trial Helpline via email to clintrialhelpline@mhra.gov.uk as well as through the usual Common European Submission Platform (CESP) route which provides a simple and secure mechanism for exchange of information between applicants and regulatory agencies.  The official acronym for the virus, Covid-19, should be included in the title field of the trial registration data set (Annex 1XML) to ensure trials relating to Covid-19 can be found and extracted easily.

For advice on any aspect of a clinical trial, the MHRA has provided the following contact details for their Clinical Trials Unit: clintrialhelpline@mhra.gov.uk or 020 3080 6456.

The Health Research Authority (HRA) should also be contacted with regard to expedited Ethics Committee opinions.  The HRA recently issued new guidance on Covid-19, which is available on their website.  This confirms that an expedited review process is available for studies relating to Covid-19 where there are public health grounds for rapid review.  Researchers should contact the HRA Director of the Approvals Service and copy in their research sponsor.  The NIHR Clinical Research Network should also be contacted.

There is also the possibility of existing studies being amended to address Covid-19 elements. All amendments requiring submission should be submitted via email and clearly marked with the subject header: IRAS ref# Amendment - COVID-19, so that they can be expedited.

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