anx_ANNEX__cpt_1__cpt_2__text_1

Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four · European Union

As regards Directive 98/79/EC, the Commission should be empowered in particular to adopt particular health monitoring measures and to amend Annex II. Since those measures are of general scope and are designed to amend non-essential elements of Directive 98/79/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

← 1.2. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331, 7.12.1998, p. 1. · All articles · anx_ANNEX__cpt_1__cpt_2__text_2 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-21 · Text as adopted (Official Journal); later amendments are not incorporated in this text.