The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, announced a set of measures taken to address hazards caused by the outbreak of Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. These measures include additional regulatory flexibilities, new standards for emergency ventilators, regulatory check for entities manufacturing test kits used to identify coronavirus, and also informed about certain changes to the workflow of the Agency itself. 

 

 

 

 

Medical Devices’ Regulatory Flexibilities in the UK

 

The outbreak of the novel coronavirus and further spreading of respiratory illnesses caused by or associated with it already resulted in significantly increasing demand on certain types of medical devices, such as ventilators, accessories thereto and other respiratory devices. To ensure the availability of such devices to healthcare authorities, national regulating authorities take certain steps to assist medical device manufacturers to meet such demand and increase the number of medical devices produced and placed on the market. Earlier in March, the Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, announced a new framework allowing to simplify the procedures to be conducted to make the device available to healthcare institutions. In particular, the FDA implemented certain exclusion regarding the changes and modifications made to the devices, allowing manufacturers to market the devices with minor changes without prior approval of the authority. Due to the public health emergency announced in the US on March 13, these changes to the regulatory framework entered into force immediately without prior public consultations.

Following the FDA, the MHRA also made certain steps necessary to accelerate all regulatory procedures and ensure the uninterrupted availability of critical supply medical devices on the market. The legal nature of these measures is the same as for ones announced earlier in the US: they came into effect immediately and should be in force for a limited period of time. These measures are aimed to create additional flexibility that is especially important under the exceptional circumstances existing nowadays. 

The scope of flexibilities announced by the MHRA covers the most important spheres. In the sphere of clinical trials, the novelties include the following ones: 

  1. Medical device manufacturers and researchers focused on seeking the treatment for the novel coronavirus could benefit from the expedited scientific advice and accelerated review of the applications for clinical trials. 
  2. The updated Good Clinical Practice (GCP) guidance implements several important amendments.
    1. The requirement to notify the regulating authority on the temporary suspension of clinical trials and also of its renewal could be waived in case of COVID-related trials,
    2. The consent could be obtained in a verbal form,
    3. It as allowed to use remote monitoring systems and technologies providing with the remote access to the records (providing that the appropriate security measures are duly taken to mitigate identified risks associated with remote connections),
    4. It is allowed to reduce the number of monitoring visits without making significant changes to the clinical trial`s plan,
    5. The authority acknowledges that sometimes safety report submission could be delayed. 

In the sphere of clinical trials, the improvements adopted by the MHRA include:

  1. The wider application of desk-based inspections instead of onsite inspections when possible,
  2. The reduction of the testing burden for medical products imported from third countries,
  3. The reduction of the testing burden for active substances in cases when the previous testing history available provides reliable and sufficient information.

Besides the aforementioned improvements covering all types of medical products, the MHRA also emphasizes certain aspects related especially to medical devices, namely:

  1. All inquiries related to the novel coronavirus will have the highest priority.
  2. Expedition of all changes to the current clinical investigations resulting from the pandemic.
  3. All COVID-related new applications for clinical investigations will be subject to expedited review. 
  4. The rule on obligatory notification of the regulating authority on protocol deviations arising due to the impact of the pandemic could be waived. At the same time, it is required to keep records that should be provided later to the authority while all other deviations should be reported in accordance with the general procedure. 

 

MHRA Specifications on Ventilators

 

As it was already mentioned before, the outbreak of COVID-19 resulted in increasing demand on respiratory devices in general and ventilators in particular. To assist medical device manufacturers focused on the development, design, manufacturing, testing and placing on the market ventilators that could be used by hospitals and other healthcare facilities, the MHRA issued specifications dedicated to the minimally acceptable performance requirements for this type of medical devices. The scope of the document covers the devices used when the patient requires invasive ventilation due to the respiratory issues occurring as the result of the impact caused by the novel coronavirus. The authority states that the devices that do not meet the lower performance threshold described in the document would not provide any clinical benefit and under certain conditions could even cause harm to patients. The MHRA also additionally emphasizes that intensive care medicine constitutes a complex set of measures. Thus, to use ventilators in a safe and efficient way, the healthcare facility needs to employ specialists with the necessary qualifications and skills. 

The lower performance ventilators falling within the scope of the document are intended to be used for a short period of time (for a few hours), and only under certain conditions, this period could be extended to 1 day. At the same time, it would be beneficial if the performance characteristics of the device would allow healthcare professionals to use it for several days in case if the patient requires more advanced ventilatory support. 

Thus, the document describes the minimal requirements ventilator shall meet be acceptable for clinical use. It also describes certain functions that are preferred but could be omitted if such omission is necessary to accelerate the procedures related to making the device available to the healthcare authorities. The document also highlights the position of the Agency on other functions and features ventilators could have, stating that these elements are less important and should not impact placing the device on the market. 

In particular, the document provides the detailed requirements ventilators should meet, including, inter alia, the following ones:

  1. Ventilation requirements (e.g. the number of modes of ventilation, the possibility to set a tidal volume and respiratory rate).
  2. Gas and electricity requirements (including the list of international harmonized standards ventilators shall comply with).
  3. Infection control requirements, providing that any element contacting with patient`s breath should be disposable or reusable.
  4. Monitoring requirements describing the way the device should alarm to bring attention to certain issues, such as gas or electricity supply failure, or pressure issues. 
  5. Biological safety requirements applicable to the raw materials used in the device, the manufacturing process, and also to the measures taken to mitigate hazards. 
  6. Software safety requirements that are especially important since ventilators are considered as high-risk devices. 

Summarizing the information described hereabove, the measures taken by the MHRA are aimed at the improvement of the existing regulatory framework to meet urgent needs caused by the outbreak of COVID-19 and respiratory illnesses associated thereto. 

 

 

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Sources:

https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19?utm_source=a2fe38b5-fb3e-40ee-b7fa-b9d611753f84&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediatehttps://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak