The Medicines and Healthcare products Regulating Authority (MHRA), the UK authority in the sphere responsible for medical devices, issued guidance dedicated to medical devices and personal protective equipment intended to be used in the context of COVID-19.

FDA

COVID-related Regulatory Background

The present MHRA guidance describes special rules and requirements for medical devices and personal protective equipment (PPE) intended to be used in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). In particular, the document is dedicated to special temporary measures implemented by the regulating authority in order to ensure and expand the availability of the vitally important medical devices during the pandemic and prevent potential shortages caused by COVID-related factors that could impact significantly the manufacturing process or supply chain. The guidance is divided into several sections, each describing the particular type of medical device or PPE.

UK Regulations on Antimicrobial Sanitisers 

The first section of the MHRA guidance provides a brief description of rules and requirements applicable to antimicrobial hand sanitizers and gels widely used during the pandemic. According to the document, these products could be additionally divided into 3 subgroups on the basis of the intended purpose and composition, namely:

  • Cleaning products that have an antimicrobial effect (in this case, an antimicrobial function is not the main one) classified as cosmetic products,
  • Disinfecting products intended to be used in healthcare institutions for general disinfection purposes, classified as biocide products, and
  • Special products intended to be used in the context of surgical procedures, classified as medicines. 

Each of the product types should be regulated accordingly. The third group is subject to strict regulation under the general medicines framework. The MHRA explicitly states that for this category of products a marketing authorization should be obtained by the manufacturer. The authority also emphasizes the importance of maintaining compliance with the applicable advertising regulations describing the way the product should be promoted by the manufacturer and the claims to be made.

infusion pumps

UK Regulations on Face Masks

Face masks are widely used in the context of the COVID-19 outbreak. According to the MHRA guidance, they could be also divided into several categories subject to different regulatory approaches. 

  • Surgical (medical) face masks intended to protect patients are Class I medical devices. Thus, as medical devices, they should comply with the requirements set forth by the applicable regulations, such as the Medical Device Regulation 2017/745 (MDR) and the Medical Devices Directive 93/42/EEC. Such devices should also have a CE mark in order to be allowed for marketing and use in the UK. However, in case even the device is not CE marked, the medical device manufacturer could still import and distribute it in the UK providing that such device would be approved for supply under the special exemption allowing to market and use medical devices without the CE mark in case if it is reasonably necessary due to the public health protection needs. The MHRA also stated that if the medical mask is supplied sterile, the appropriate certificate should be issued by the notified body entitled to confirm this. 
  • Face masks intended to protect the person wearing it are personal protective equipment and thus should be treated accordingly. Such face masks are not medical devices.
  • Face covering is an entirely separate type of products that are neither personal protective equipment nor medical devices. This category covers the products designed to be used by the general public. According to the MHRA guidance, such products should meet the requirements set forth by the General Product Safety Regulations 2005 (GPSR). The aforementioned document also describes the obligations of the manufacturers and suppliers of face coverings. At the same time, these products are actually falling outside of the scope of MHRA`s responsibility.

UK Regulations on Medical Gloves

In accordance with the present MHRA guidance, in case if the manufacturer claims that the particular gloves are intended to be used by healthcare professionals, such gloves should be regulated as medical devices. This category includes medical examination gloves and surgical gloves used in the context of the examination and surgical procedures respectively.

As it is stated by the MHRA, medical gloves should comply with the requirements set forth by the MDR and MDD, and also should bear a CE mark. At the same time, the manufacturer is still allowed to apply for an exemption based on the public health protection needs allowing to market and use medical devices that are not CE marked. 

It is also important to mention that while both being medical devices, examination gloves and surgical gloves are treated differently under the existing legislation. 

  • Examination gloves are classified as Class I (low-risk) medical devices or Class I sterile medical devices (if applicable – in this case, the appropriate certificate should be issued by a notified body).
  • Surgical gloves are classified as Class IIa medical devices and should have a certificate issued by a notified body duly designated to perform the conformity assessment of the medical devices of such type and class. 
  • Any medical gloves coated with an antimicrobial agent are classified as Class III medical devices and require a CE certification.

In the case that the particular gloves are intended to protect the person wearing them, such gloves should be regulated as personal protective equipment and thus should comply with the appropriate PPE requirements. At the same time, it is also important to mention that the application scope of Medical Devices Directive 93/42/EEC also covers products regulated as personal protective equipment providing that such products could be used either for medicinal or non-medicinal purposes. Thus, such gloves should comply with both requirements set forth in the MDD and PPE regulations.

EUA eligibility criteria checklist

Other Requirements 

Besides the aforementioned, the MHRA also provides general information regarding compliance with the applicable regulations, and also about the consequences of non-compliance. For instance, the authority warns about the special actions to be taken against any entity marketing medical devices without obtaining the approval required for the appropriate type of medicinal products.

Summarizing the information provided here above, the MHRA guidance describes the requirements applicable to the medical devices, personal protective equipment, medicines, and other products intended to be used in the context of the COVID-19 outbreak. In particular, the document describes the requirement they should meet depending on the type and regulatory status. As it is stated in the guidance, the regulatory approach in most cases depends on the intended purpose of the product claimed by the manufacturer. Under the general rule, the products intended to be used for medicinal purposes and/or by healthcare professionals are subject to stricter requirements in comparison to ones intended for the general public use.

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Sources:

https://www.gov.uk/guidance/regulatory-status-of-equipment-being-used-to-help-prevent-coronavirus-covid-19


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