How do you create protective armor

Directive representative for personal protective equipment (PPE)

General

Personal protective equipment within the meaning of Regulation (EU) 2016/425 (PPE Regulation) Equipment designed and manufactured to be worn or held by a person as protection against one or more risks to their health or safety (Legal definition).

A PPE should therefore always symbolically have a "sign"between the danger / hazard and the person carrying or holding it. This symbol can also be found in the pictograms that can be found on personal protective equipment:

(Examples of pictograms)

A recurring question and a point of discussion between manufacturers / dealers and supervisory authorities is whether a product is personal protective equipment and if yes, in which category it is to be classified.

The ZLS a tool, the category finder, which provides more clarity with the answer to five questions. Although not every question can be clarified with this tool, but it always creates a clue.

To the category finder download for the PPE Directive (requires Microsoft Excel or a program that can process MS Excel files)

To the category finder download for the PPE regulation (requires Microsoft Excel or a program that can process MS Excel files)

Categories of personal protective equipment

The categorization of personal protective equipment is used to carry out various graded conformity assessment procedures when it is placed on the market.

Category I.

The manufacturer / distributor must have technical documentation for his product and keep it available for inspection by the supervisory authority. With the introduction of Regulation 2016/425 / EU, the declaration of conformity is also part of the product. The manufacturer must either enclose it or at least have a web link in the instructions where it can be found. The products also require instructions and must permanently bear the "CE" mark.

Category II

In addition to the obligations under Category I, the manufacturer / distributor must have a valid EU type examination certificate from a notified body (see NANDO) for his product in order to be able to declare conformity.

Category III

In addition to the obligations under Category II, the manufacturer / distributor must follow a procedure under Art. 19 c. of the PPE Ordinance (Module C2 Annex VII or Module D Annex VIII) carried out by a notified body. In this case, the CE marking of the product must be expanded to include the four-digit (NANDO) number of the position, e.g. CE1234.

Assistance with the categorization

Even for an expert, it is not always easy to categorize a product correctly. Often it is only after years of European discussion that it is clarified whether a product is to be regarded as PPE at all and, if so, under which category it falls. In order to provide assistance, guidelines have been drawn up under the leadership of the Commission, which are intended to ensure uniform application of the PPE Regulation across Europe. However, these guidelines have no legal character and are, according to the European Commission, a non-binding document. The guidelines for the PPE regulation in the version April 2018 In some places do not correspond to Germany's legal opinion and should therefore be applied very carefully.

Guidelines in English (PPE guidelines for the PPE directive, official PDF document of the European Commission)

Guidelines in English (PPE guidelines for the PPE regulation, official PDF document of the European Commission)

European contacts and contact points

Are you looking for a contact person for PPE in other European countries? Follow this link.

Do you have any questions on the topic or on the duties of the guideline representatives?

Contact Person:

Benedikt Brugger
Tel. 089/9214 3244
benedikt.brugger (at) zls.bayern.de