Most of the equipment being used as protection against airborne particles and small droplets are covered by specific EU harmonised legislation. The vast majority of these products are classified as Personal Protective Equipment (PPE) and fall under the scope of Regulation (EU) 2016/425. These products are intended to protect the wearer.
Products that are intended to protect the patient, such as medical gloves and medical face masks, will fall under the scope of the Medical Device Directive 93/42/EEC (MDD) (to be replaced by the Medical Device Regulation 2017/745 (MDR)).
Meeting either of the above legislation will allow the manufacturer to legally affix the CE mark and circulate freely in the EU. The essential requirements of the PPE Regulation and the MDD may be met by following harmonised standards, which are published in the Official Journal of the European Union. Following this technical solution, conformity to the essential requirements may be presumed.
The following harmonised standards are applicable to face masks:
FFP-Type [PPE] EN 149:2001+A1:2009
Medical [MD] EN 14683:2019+AC:2019
These standards may be obtained through the following link.
The manufacturer is not required to meet all the specifications of these standards and can adopt different technical solutions. However, due to the presumption of conformity, time-to-market may be reduced drastically.
The manufacturer may decide to carry out the tests prescribed in the harmonised standards themselves or outsource this testing to a laboratory. Should the manufacturer follow these standards, the EU Competent Authorities may take a product sample and test these in accordance with the tests prescribed in the standard as part of market surveillance procedures.
Additional technical solutions and guidelines have been compiled in a list by the World Health Organisation. However, in following one of these alternative standards referred to by the WHO for PPE products, the manufacturer shall submit a sample to be tested by a designated notified body. The EU Commission has urged notified bodies to prioritise new requests for COVID-19 related PPE. In a Recommendation issued on 13 March 2020, the Commission encourages notified bodies to adopt derogations which will allow speedier market access under certain conditions.
- Point 7 of the Recommendation allows manufacturers to anticipate the placement of their products on the market whilst the conformity assessment procedures are being finalised.
- Point 8 of the Recommendation allows manufacturers to place their products on the market even if no conformity assessment procedures have been initiated.
Under the MDD and the MDR, medical face masks and examination gloves are considered to be class I medical devices, and as such are dependent on self-assessment and will not require notified body intervention. However, if provided in a sterile state, a notified body will be required to assess those aspects of sterility.
On the other hand, face masks and equipment used to protect against COVID-19 and are covered by the PPE Regulation are classified as Category III PPE, and thus a notified body must be involved.
In both cases, PPE and medical devices must be placed on the market with the EU/EC Declaration of Conformity document, as well as the accompanying CE Certificate issued by the notified body, when applicable. No other documents are required for market access, however, there are some additional considerations to keep in mind.
Issuing a Declaration of Conformity (DoC) signifies that you comply with that specific EU Regulation / Directive and that you have met all their requirements. Part of these requirements will be to develop and maintain a set of technical documentation.
Medical devices falling into class I, must be registered with the applicable EU Competent Authority in the country in which the manufacturer or their EU Authorised Representative is based.
For more information on how to lawfully place your PPE or medical devices on the EU market, please do not hesitate to contact us at firstname.lastname@example.org.