引言：近日，欧洲安全联盟在其官方 网站上发文明确：防护口罩等个人防护用品（PPE）需满足REACH法规等要求，详见正文。

医疗器械CE认证.jpg

conformity assessment procedure for PPE

remark : this article is valid for Personal Protective E (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 re 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”.

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 Re (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 theNANDO databaseof the EU Commission to find a Notified Body competent for your product.

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).