What are directives?

Directives are regulatory provisions the implementation of which is mandatory for all EU Member States. Directives are developed by the European Commission in order to create a uniform body of provisions to enable elimination of barriers to trade and to ensure a free movement of goods, meeting essential requirements with regard to safety of products for people and for the environment. Poland’s key legal act transposing directives to the domestic law is the Conformity Assessment System Act of 30 August 2002 (Journal of Laws of 2021, item 1344), provisions of the act of 13 April 2016 on conformity systems and market supervision (Journal of Laws of 2022,  item 5) and the Act of 12 December 2003 on General Product Safety (Journal of Laws of 2021,  item 222).

Provisions of the act on exercising compliance with medical articles, also for agri-food products and animal nutrition. Some directives take into account the key elements of research and certification and the rules of designation of bodies participating in the product assessment; they also harmonize the rules of application of the CE mark. Directives apply to products which are to be placed on the market or put into service for the first time. The manufacturer is responsible for meeting essential requirements, declares the product’s conformity to the requirements on its own, and remains responsible for its accuracy. The manner in which essential requirements are to be met is entirely at the manufacturer’s discretion. The PKN wishes to emphasise that the manufacturer has a choice; it may manufacture its product and verify its conformity directly with regard to a directive, or it may manufacture its product in accordance with the requirements of a harmonized standard, the result being that the product’s conformity to the directive’s essential requirements is merely implied. For more information on the Directives visit the European Commission’s website.