Surgical robots as medical devices Sample Clauses

Surgical robots as medical devices the Directive 93/42/EEC The da Vinci system (CE 0543) belongs to the category of Class IIb medical device according to the classification based on the Annex IX of the Council Directive 93/42/EEC of 14 June 1993 (henceforth MDD).2 Art. 4 MDD provides that Member States (MS) shall not create any obstacle to the placing on the market or the putting into service, within their territory, of devices bearing the CE marking. In order to obtain the CE marking, and thus meet the safety requirements, that allow the distribution of the product within the European market, Class IIb devices need to undergo either the procedure for the declaration of conformity set out in Annex II (full quality assurance), or the type-examination set out in Annex III. In the first case, the examination of the design of the product (point 4 of Annex II) is not required; in the second case instead, the manufacturer is also required to comply with one of the three procedures set forth respectively by Annex IV, V or VI, namely the EC verification the EC declaration of conformity (production quality assurance), or the EC declaration of conformity (product quality assurance). The EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of the MDD (point 1 Annex III). The notified body is a third party – either a national public authority or a non- governmental entity, designated by MS, and notified to the Commission and other MS (art. 16 MDD) – that assesses the conformity of the devices, by carrying out the procedures referred to in art. 11. The Commission periodically updates and publishes in the Official Journal of the European Communities a list of the notified bodies, together with the tasks for which they have been notified, assigning an identification number. To obtain the CE marking, medical devices have to respect (art.
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