conformity assessment procedure for PPE
remark : this article is valid for Personal Protective Equipment (PPE), such as protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc. The conformity assessment procedures for medical devices (e.g. medical or surgical masks) are different and for those you should seek information from the relevant trade associations or authorities. The manufacturer must also check of other legislation is simultaneously applicable to the product (e.g. REACH is always applicable).
Compliance with the EU legislation on PPE (Regulation (EU) 2016/425) ensures that PPE are safe to be used by the wearer and at the same time offer the necessary and claimed protection. Having the same legislation in the EU (+EFTA/EEA and some other European countries) is obviously a key element for the single market.
The COVID-19 crisis does not change the fact that PPE must be safe for the wearer, nor that the PPE must protect the wearer as claimed by the manufacturer. Even if some deviations of the conformity assessment procedures are made possible with the Commission Recommendation 2020/403, the essential health and safety requirements for PPE can under no condition be ignored. These exceptions are in any case limited for PPE used by healthcare workers. For more information on this specific aspect, see the page “exceptions to the conformity assessment rules for PPE”. (remark 15/02/2021 : in several countries, the exceptions are no longer applicable, only PPE that are fully compliant with the PPE Regulation, including the full conformity assessment procedure are acceptable on the market, including for the healthcare sector).
The conformity assessment procedure is the responsibility of the manufacturer of the PPE. First step is to make a risk analysis, defining what protection is offered by the product and what the foreseeable use (and misuse) is. Based on this, the category of the PPE is defined (for instance for respiratory protection that is always category III).
The technical file must contain this risk analysis but also all information about the product, the production control, the user instructions etc. The file must also contain information on how the manufacturer proves compliance with the applicable Essential Health and Safety Requirements (annex II of the PPE Regulation). The most common way to demonstrate compliance is by using harmonised European standards, but also other technical specifications can be acceptable.
In the case of category II and III PPE (which are the vast majority of PPE), the manufacturer must apply for a type examination by a Notified Body which results in an EU Type Examination Certificate. For category III PPE (such as protective masks), this also needs to be completed with a follow-up of the production by a Notified Body. See the NANDO database of the EU Commission to find a Notified Body competent for your product (our member BSIF made a video on how to use the NANDO database)
Once this completed, the manufacturer has to mark the product with the CE mark (in case of category III followed by the number of the Notified Body responsible for the production follow-up) together with his name (and address), the reference of the product and reference of the standard used (for full list of what needs to be included in the marking, see the Regulation, e.g. article 8 (obligations of manufacturers) and also the (European) standards).
The manufacturer must prepare the Declaration of Conformity which needs to be included with each product (or at least a link to the document must be available with the product) and ensure that procedures to remain in conformity are in place for the series production of the PPE. This Declaration of Conformity is the only document that needs to accompany the PPE and that the manufacturer needs to share with his customers.
All PPE have to be accompanied by the instructions for the user in the language of the country where the PPE will be sold (see annex II paragraph 1.4 of the PPE Regulation for the minimal content).
See also guidance document "How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used - also in the COVID-19 context" published by the EU Commission. Further information on the EU PPE Regulation is available on the PPE webpage of the EU Commission DG GROW.