Procedure for Assessing the Conformity of Personal Protective Equipment

EFFECTIVE APRIL 21, 2018:
Personal protective equipment (PPE) is a designated product that, as of April 21, 2018, falls under the harmonized scope of Act No. 90/2016 Coll. The amendment to Act No. 90/2016 Coll. by Act No. 265/2017 Coll. also implements Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment. Regulations are directly applicable throughout the EU and in individual Member States (MS). MS are required to apply them directly without further implementation in national legislation.
Note: Council Directive No. 89/686/EEC was repealed on April 21, 2018, and replaced by Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment. Conformity assessment procedures under the new Regulation (EU) 2016/425 of the European Parliament and of the Council are outlined in the chapter: Conformity Assessment Procedure for PPE under the New Regulation. Products that comply with Council Directive 89/686/EEC and were placed on the market before April 21, 2019, may continue to be supplied to the market. EC type-examination certificates and approval decisions issued under Council Directive No. 89/686/EEC remain valid until April 21, 2023, unless their validity expires before that date.

UNTIL APRIL 21, 2018:
Personal protective equipment (PPE) consists of specified products defined by Act No. 22/1997 Coll., which fall within the harmonized scope. Personal protective equipment must meet the essential health and safety requirements set out in Annex 2 of Government Regulation No. 21/2003 Coll. Government Regulation No. 21/2003 Coll., which lays down technical requirements for personal protective equipment, implements Council Directive 89/686/EEC. Personal protective equipment that complies with Government Regulation No. 21/2003 Coll. may continue to be supplied to the market provided it was placed on the market by April 20, 2019. Valid EC type-examination certificates and other documents issued by notified bodies pursuant to Government Regulation No. 21/2003 Coll. remain valid for a period of 5 years from the date of entry into force of this Regulation, unless a shorter validity period is specified therein. Notified bodies authorized to perform conformity assessment activities for personal protective equipment under Government Regulation No. 21/2003 Coll. may continue to carry out such activities until April 20, 2019.

The European Commission has issued guidance for the transition period regarding the transition of PPE from Directive 89/686/EEC to Regulation (EU) 2016/425 of the European Parliament and of the Council: "GUIDANCE DOCUMENT ON THE PPE TRANSITION FROM DIRECTIVE 89/686/EEC TO REGULATION (EU) 2016/425"

The essential requirements for PPE are considered to be met if the personal protective equipment complies with a harmonized Czech technical standard or with a foreign technical standard that transposes a harmonized European standard in EU Member States.

Classification of Personal Protective Equipment (PPE)

Depending on the degree of potential risk associated with the use of the product, PPE is classified into three groups (categories). Directive 89/686/EEC defines only the first and third categories in detail; all remaining PPE is classified into the second category. The classification of PPE into individual categories is, by law, the responsibility of the manufacturer or importer. In case of doubt, the categorization may be consulted with the relevant notified body; in the event of a dispute, only a court has the final and decisive say.

Category 1 PPE

Personal protective equipment of simple design for which the manufacturer or importer can assume that the user is capable of assessing the level of protection against risks that can be recognized by the user in a timely and safe manner. This includes, for example, PPE protecting against superficial mechanical effects (gardening gloves), against temperatures up to 50 °C, against climatic influences that are not extreme, against minor impacts, or against solar radiation (sunglasses).

Category III PPE

Personal protective equipment intended to protect life or to protect against risks that may seriously and permanently harm health, and for which the manufacturer or importer can assume that the user is unable to recognize these hazards in a timely manner. This category includes PPE for respiratory protection, protection against temperatures above 100 °C or below -50 °C, all PPE for fall protection, etc.

Category II PPE

The remaining personal protective equipment, which by its nature does not meet the definition of either the first or third category, is classified in the second category.

Conformity assessment procedures for individual categories

Directive 89/686/EEC prescribes different conformity assessment procedures for the individual categories of PPE. The diagram of procedures applicable to individual categories of personal protective equipment is shown in the following table. The table also serves as a guide for manufacturers in categorizing PPE and in deciding which of the alternative conformity assessment procedures for Category 3 personal protective equipment to choose.

Table: Overview of PPE Conformity Assessment Procedures

The manufacturer or importer decides whether the PPE is of simple design
Yes Category I PPE	No Category II or III PPE
The manufacturer (importer) compares the characteristics of the PPE with the essential requirements of Annex II to Directive 89/686/EEC and compiles the necessary technical documentation in accordance with Annex III	The manufacturer (importer) shall compile the necessary technical documentation in accordance with Annex III of Directive 89/686/EEC and submit it to the notified body together with an application for conformity assessment.
The notified body shall carry out the EC type examination in accordance with Article 10 of the Directive
The manufacturer (importer) shall determine whether the PPE is intended to protect life and to protect against risks that may seriously and permanently endanger health
No Category II PPE	Yes Category III PPE
The manufacturer (importer) chooses the method of annual inspection:
EC product quality management system in accordance with Article 11A of Directive 89/686/EEC	EC production quality assurance system through surveillance pursuant to Article 11(B) of Directive 89/686/EEC
The manufacturer (importer) issues a declaration of conformity and affixes the CE marking to each product.

EC type
examination: EC type examination is a procedure in which a notified body verifies and certifies the conformity of PPE with the requirements of Directive 89/686/EEC, as amended. The application for EC type examination is submitted by the manufacturer or their authorized representative; the application must be accompanied by an adequate number of samples and a set of technical documentation in accordance with the requirements of Directive 89/686/EEC.

The
CEmarking on personal protective equipment indicates compliance with the technical requirements of the product in accordance with all applicable legal regulations that the PPE manufacturer has applied. The CE marking on personal protective equipment also indicates compliance with the established procedure for assessing its conformity. If a notified body is involved in the PPE production process, its notification number must also be included.