25 Mar Recommendation to allow protective equipment without CE marking
Recommendation to allow protective equipment without CE marking
There is a recommendation from the EU to allow personal protective equipment without CE marking
The requirements for the placing of personal protective equipment (PPE) on the market are laid down by Regulation (EU) 2016/425 of the European Parliament. Personal protective equipment, such as face masks, must be CE-marked if these products appear on the market within the European Union (EU). These items must follow the NEN standard. Due to the high demand within the EU for personal protective equipment, there is a recommendation that under specific circumstances some medical devices (e.g. face masks used for medical purpose) may be made available on the Union market, even if they do not yet bear the CE mark. In the Netherlands, the Social Affairs and Employment Inspectorate (SZW) and the Health and Youth Care Inspectorate (IGJ) are following up on this recommendation by allowing the placing of PPE and medical devices on the market that do not have a CE mark, but which do comply with the legal health and safety requirements.
As already indicated, these items still have to follow the NEN standards. In most cases, these European requirements are almost identical to the rules in a production country, such as the United States or China. If the personal protective equipment is not yet certified, a so-called ‘notified body’ can do this, for example SGS UK. If this inspection takes place in the EU by a notify body, this body may also be located in another EU Member state. The disadvantage here is that the products have already been imported and in most cased the import duties and VAT have already been paid.
Based on the EU Personal Protective Equipment regulation 2016/425 (as of May 21, 2020, 2017/425), manufacturers, authorized representatives, importers and distributors of personal protective equipment have to comply with the following legal obligations:
- Essential requirements of the regulation
- Technical requirements
- Involve a notified body (e.g. SGS UK)
- User manual (if necessary)
- Security data
- Manufacturer’s contact details on product
- Declaration of conformity (manufacturer remains fully responsible)
In most cases, a manufactures who wants to bring personal protective equipment to the market has to affix a CE marking to these items. This marking initially has to be affixed to the products themselves. However, if this is not possible or unjustified due to the nature of the items, the manufacturer has to affix the CE marking to the packaging and accompanying documents. The verification of these markings are different in some cases due to the different categories in which the risks of the personal protective equipment are considered (please see the categories below). Personal protective equipment in category I, an internal production control by th manufacturer is enough. In categories II and III, a type approval is needed to get the CE marking. In this case, a notified body always has to check this, such as SGS UK or in China.
All personal protective equipment is classified according to the risk categories, which you can see in Annex 1. These are:
- Category I – minimal risks
- Category II – risks other than those mentioned in categories I and III
- Category III – risks that can have fatal or irreversible consequences
Depending on the category, the manufacturer has to carry out a conformity assessment procedure as described in article 19 and in Annexes IV to VIII.
In the document below you will find the article and the various annexes.
If you require more background information or need advice, please contact one of the consultants at SGS Maco or one of the listed authorities. We are happy to help.