5 Amendments of Sabine VERHEYEN related to 2013/0049(COD)
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 3 – point d a (new)
Article 2 – paragraph 3 – point d a (new)
(da) medicinal devices as referred to in Directive 93/42/EEC concerning medicinal devices, Directive 90/385/EEC concerning active implantable medical devices and Directive 98/79/EC concerning in vitro diagnostic medical devices;
Amendment 129 #
Proposal for a regulation
Article 3 – point 1
Article 3 – point 1
(1) ‘safe product’ means any product which is genuine and which, under normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of persons;
Amendment 189 #
Proposal for a regulation
Article 7
Article 7
Amendment 237 #
Proposal for a regulation
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where. If thatis is not impossible, on its packaging or in a document accompanying the productaccount of the size, nature or packaging of the product, only the trade mark shall be indicated. The address must indicate a single point at which the manufacturer can be contacted.
Amendment 283 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Before making a product available on the market distributors shall verifycheck with the requisite care that the manufacturer and the importer have complied with the requirements set out in Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable.