New Legislative Framework (NLF)

The New Legislative Framework (NLF) provides a framework for regulations and standards in the harmonized area (directives drafted under the NLF) and consists of the following three horizontal documents:

a)  Decision No. 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and repealing Council Decision 93/465/EEC, as amended on July 1, 2015.

This decision establishes common principles for the revision or recasting of New Approach directives. The Decision is binding primarily on the legislative bodies of the European Community. It primarily affects other entities as reference material for harmonized Community regulations already issued regarding the placing of products on the internal market of the European Community.A handbook

has been issued for the implementation of directives based on the new legislative framework, which replaces The Blue Guide on the implementation of EU product rules, 2016; see also the Czech version, "Modrá příručka."

b) Regulation (EC) No. 765/2008 of the European Parliament and of the Council (consolidated version), laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93, as corrected on July 3, 2015,

• supplemented

• by Commission Implementing Decision No. (EU) 2024/581 on a harmonized standard for the accreditation of medical laboratories in support of Regulation (EC) No. 765/2008 of the European Parliament and of the Council

. This Regulation is directly applicable in the Member States and establishes:

• rules for accreditation;
• rules for market surveillance;
• rules for controls on products from third countries;
• rules for CE marking.

c) Regulation (EU) No.2019/515 on the mutual recognition of goods lawfully placed on the market in another Member State and repealing Regulation (EC) No. 764/2008
. Regulation (EC) No. 764/2008 of the European Parliament and of the Council was repealed on April 19, 2020, by Regulation (EU) No. (EU) 2019/515.


Harmonized standards for the New Legislative Framework and management systems.