§1.2.2.1 Regulation (EC) No 765/2008 and Regulation (EU) 2019/1020

Regulation (EC) No 765/2008 imposes clear obligations on Member States who do not have to transpose its provisions (although many may have to take national measures to adapt their national legal framework). Its provisions are directly applicable to the Member States, to all the economic operators concerned (manufacturers, distributors, importers) and to conformity assessment bodies and accreditation bodies. Economic operators now have not only obligations but direct rights that they can enforce through the national courts against both national authorities and other economic operators for non-respect of the provisions of the Regulation. While the provisions on accreditation and CE marking remain applicable, the provisions on market surveillance in Regulation (EC) No 765/2008 have been repealed and replaced by Regulation (EU) 2019/1020. In the presence of other EU legislation, both Regulations apply first and foremost, a) on the basis of being directly applicable i.e. national authorities and economic operators must apply the provisions of these Regulations as such (most of the other legislation is contained in directives) and b) on the basis of the lex specialis rule i.e. whenever a matter is regulated by two rules, the more specific one should be applied first. In the absence of more specific legislation on the issues covered by its provisions, Regulation (EC) No 765/2008 will apply at the same time, with, and as a complement to, existing legislation. Similarly, Regulation (EU) 2019/1020 is based on the lex specialis principle, providing that this Regulation applies insofar as there are no specific provisions with the same objective in Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement (Article 2(1) of Regulation (EU) 2019/1020). Where existing legislation contains similar provisions as the Regulation, the corresponding provisions will have to be examined on a one to one basis to determine which is the most specific. In general terms, relatively few EU legislative texts contain provisions relating to accreditation, so it can be said that Regulation (EC) No 765/2008 is of general application in this area. In the area of market surveillance (including the control of products from third countries) the situation is more complex, as some Union harmonisation legislation does have various provisions relating to the issues covered by Regulation (EU) 2019/1020 (e.g. legislation on medical devices and on in vitro diagnostic medical devices which provides for a specific information procedure). In many cases, the market surveillance provisions in Union harmonisation legislation are complementary and provisions of Regulation (EU) 2019/1020 remain applicable.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07