As the UK move to the recovery stage from the Covid-19 pandemic, Government advice to citizens encourages the use of face coverings in situations where guidelines on social distancing are difficult to achieve. Face masks and coverings are the most common forms of protection and many manufacturers are looking to supply these products to the UK to prevent shortages. In this article, we briefly describe the differences between the types of protective products and the regulatory requirements given the current health crisis.
Broadly speaking there are 3 categories of face masks and coverings:
- Surgical face masks – intended to limit the transmission of infective agents from the nose and mouth of a carrier or patient with clinical symptoms. These offer a barrier to infection of others, though offering limited protection to the wearer.
- These products are designated as a Class I medical devices, regulated under the European Medical Devices Regulation or Directive and may require notified body involvement if sterilised.
- Protective face masks – designed to protect the wearer against particulates such as dust particles and viruses. They are also used in domestic, industrial and healthcare applications.
- These products are designated as Personal Protective Equipment (PPE), regulated under the European Personal Protective Equipment Regulation and must be certified by a notified body in all cases.
- Face coverings – intended to be used by the general public to reduce public risk of disease transmission. In the absence of formal standards for this application in Covid-19 context, countries have developed their own requirements for this type of product.
- In the UK, these products are covered by the General Products Safety Regulations 2005.
In response to the Covid-19 crisis and based on the recommendations from the European Commission (EU Recommendation 2020/403), the UK government has introduced 3 fast-track procedures which allow certain types of face mask medical devices and PPE to be sold lawfully without a CE mark.
Firstly, if the face mask is classified as a medical device, then the requirement is to meet the design and safety requirements of the Medical Device Regulations (Directive 93/42 or Regulation 2017/745) and be CE marked before being sold in the UK. However, if the medical device is not already CE marked, you may apply for an exemption from the regulations with the MHRA who can authorise supply of non-CE marked devices in the interest of protecting health. In this case, a list of requirements still needs to be fulfilled together with sufficient evidence that the device performs as intended. While class I medical devices are self-assessed, the exemption procedure would benefit those who have not fully compiled their technical documentation to the requirements Medical Device Regulations.
Secondly, if the face mask if classified as a PPE, it is necessary to be CE marked by a notified body under the European Personal Protective Equipment Regulation (EU Regulation 2016/425). There are however now 2 exemption procedures that may apply depending on the distribution pathway.
- If the product is intended to be sold directly to the UK Government as part of a Government procurement for use by healthcare workers, then the Office of Product Safety and Standards (OPSS) will instead assess the product and determine if it meets the essential requirements. No notified body is involved in this procedure which means the product cannot be CE marked.
- If you are selling PPE directly to end users (including hospitals and care homes) then a separation derogation applies. This derogation does not remove the requirement for CE marking completely, rather is allows a manufacturer to ship their product to a customer before the CE marking process if fully complete. In this case, the manufacturer must have an engaged a notified body who would have completed some basic checks. Note: the CE mark cannot be applied to the product until full authorisation has been completed. Current estimates are that these basic checks take about a week to complete.
In both cases, manufacturers or importers in the UK must have documentary proof of compliance to each pathway.
Further to these fast-track procedures, there is another procedure which has been agreed by the PPE notified bodies and the European Commission. This consists of a simplified set of tests which have been selected specifically for Covid-19 that diverge from the harmonised standards.
Lastly, for face coverings which does not require CE-marking at all. These products can be made available easily under the General Product Safety Regulations 2005 provided that do not make any medical or protective health claims.
For over 15 years, RNI CONSULTING has been providing regulatory, scientific and clinical solutions to clients for the development of health products. Our vast expertise covers formulation development, communication assessment, marketing authorisation and claim substantiation. RNI CONSULTING’s work method is based on solid regulatory and scientific competencies together with strong relationships with European, British and International authorities.
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