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The consolidated negotiated texts for the medical device and the IVD regulations are available

The trilogue negotiations are completed and the proposal regulations could be presented by the Council to the European Parliament for a formal vote within the next months. If adopted by the Parliament in its second reading, the legislative texts could be published after the translations and the Legal review in the first months of 2017 coming into full effect three years later in 2020.However, some changes can still occur with possible delays in implementation. A critical point is the Article 9 regarding authorized representatives:"4a. Without prejudice to paragraph 4, where the manufacturer is not established in any Member State, and has not complied with the obligations laid down in Article 8, the authorised representative shall be legally liable for defective devices in accordance with Article 8(13) on the same basis as, jointly and severally, with the manufacturer. "

In case that this article is not modified by the Commission, it will be hard for current independent EAR to stay in business.

See also MediMark comments in the "Private News", last line of the section "Members"

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