Ensuring product safety when producing personal protective equipment (PPE)
As the UK authorities are scrambling, increasingly desperately, for supplies of personal protective equipment (PPE) in order to provide health workers with the necessary tools to protect them in the fight against the COVID-19 pandemic, industry and academia are stepping up in order to fill the gap.
Set against these good intentions are the necessary rules that govern product safety in the EU. These are set out in the CE Marking Regulation, Regulation 765/2008, which lays down the definition, the format and general principles governing CE marking (together with EU Decision 768/2008, which provides for assessment procedures that lead to its affixing).
CE marking is a certification mark that indicates a product conforms to health, safety, and environmental protection standards when sold within the European Economic Area (EEA).
In addition to the general CE Marking Regulation, there are two specific, product-specific directives:
- The Medical Devices Directive (Directive 93/42); and
- The Personal Protective Equipment Regulation, Regulation 2016/425 (which replaces the PPE Directive (Directive 89/686)).
What are the current regulations and legislation relating to PPE?
There is a necessary interaction between the above two legislative provisions, so that where a device is both a medical device and is intended to be treated as PPE, it must meet both the rules of the Medical Devices Directive and also the relevant basic health and safety requirements of the PPE Regulation.
Does PPE have to be CE marked?
In general, many products require CE marking before they can be sold in the EEA. This means that the manufacturer is responsible for checking that their products meet EU safety, health and environmental protection requirements; carrying out a conformity assessment; setting up a technical file; issuing the EU declaration of conformity; and affixing the CE marking to a product. Only then can the product be traded on the EEA market.
Conformity assessment rules for PPE
As well as identifying any applicable standards, and checking whether the product meets those specific requirements, it is sometimes necessary to identify whether the product needs to be independently verified. This is described as a conformity assessment by a third party (a “notified body”). For some products that present higher safety risks, a notified body must verify that the product meets the specific technical requirements.
For example, medical masks (when supplied in a non-sterile condition) are treated as “Class I” medical devices, which a manufacturer can self-certify meet the applicable standard. On the other hand, surgical face masks used in the COVID-19 context that are covered by the PPE Regulation are considered as “Category III” PPE and require, in principle, an EU-type examination by a notified body.
By way of a derogation from the rules regarding CE marking, the EU Commission has issued guidance to national market supervisory authorities that PPE that has not gone through this process, (and does not have CE marking) may, exceptionally, be exempt from these requirements. However, this is provided that it meets the following cumulative conditions:
- the products are manufactured in accordance with one of the EN standards, or in accordance with any of the other standards referred to in the WHO guidelines or a technical solution ensuring an adequate level of safety;
- the products are part of a purchase organised by the relevant member state authorities;
- the products are only made available for healthcare workers;
- the products are only made available for the duration of the current health crisis; and
- the products are not entering the regular distribution channels and being made available to other users.
How to get approval of PPE being produced to support the COVID-19 outbreak
More information on how to get fast-track approval of medical devices during COVID-19 can be found on the gov.uk website.
You can send exemption/derogation requests for PPE to the Department for Business, Energy and Industry Strategy (BEIS) by email here.
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