Statutory regulations for EU-wide market access
The prerequisite for personal protective equipment (PPE) to fulfil its protective function and to be placed on the market is that it must comply with statutory regulations. This page set outs these requirements in greater detail.
The legal framework for the placing of new PPE on the market is the European PPE Regulation (“Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC”) which came into effect on 20 April 2016. This Regulation replaces the PPE Directive 89/686/EEC and primarily addresses manufacturers. After a transitional period of two years, the PPE Directive is repealed with effect from 21 April 2018, from which time the new PPE Regulation applies. Legal specifications regarding the PPE-Regulation’s implementation in Germany are contained in the Law for the Implementation of the PPA Regulation (“Gesetz zur Durchführung der Verordnung (EU) 2016/425 des Europäischen Parlaments und des Rates vom 9. März 2016 über persönliche Schutzausrüstungen (PSA) und zur Aufhebung der Richtlinie 89/686/EWG des Rates (PSA-Durchführungsgesetz - PSA-DG)”) that came into effect on 26. April 2019.
The PPE Regulation establishes the conditions for the placing on the market and free movement of PPE within the European Community. It also formulates the basic safety requirements that PPE must meet in order to protect users' health and guarantee their safety. These requirements are defined in Annex II and apply regardless of the intended use (private or commercial).