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Conformity Assessment Procedures for Protective Equipment

The COVID-19 is transmitted via small airborne droplets emitted by infected people when sneezing, coughing or talking.
Therefore, a wide array of protective products designed to ensure protection against airborne particles or small droplets
are used such as: face masks, gloves, coveralls, etc.

Most of these products are among the so-called ‘harmonised products’ for which there is specific EU product legislation
in place. A majority of the products used in the context of the current health crisis, including FFP-type masks, are
considered as Personal Protective Equipment (PPE) and hence fall under the scope of Regulation (EU) 2016/425.

Other products such as medical gloves, surgical masks, intensive care and other medical equipment are products falling
within the scope of the EU legal framework on medical devices – Council Directive 93/42/EEC, to be replaced by
Regulation (EU) 2017/745 as from 26 May 20201.

Each of the two legal frameworks fully harmonises the performance requirements for the products that it covers in order
to ensure protection of the health and safety of users. Thus, products manufactured in accordance with these rules can
circulate freely throughout the internal market and Member States may not introduce additional and diverging
requirements regarding the manufacturing and placement on the market of such products.


Published: 27th March 2020

Source: European Commission, Medical Devices