BETA

5 Amendments of Birgit COLLIN-LANGEN related to 2013/0049(COD)

Amendment 120 #
Proposal for a regulation
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;
2013/09/16
Committee: IMCO
Amendment 129 #
Proposal for a regulation
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;
2013/09/16
Committee: IMCO
Amendment 189 #
Proposal for a regulation
Article 7
Article 7 Indication of the origin 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product. 2. For the purpose of determination of the country of origin within the meaning of paragraph 1, non-preferential origin rules set out in Articles 23 to 25 of Council Regulation (EEC) No 2913/92 establishing a Community Customs Code shall apply. 3. Where the country of origin determined in accordance with paragraph 2 is a Member State of the Union, manufacturers and importers may refer to the Union or to a particular Member State.deleted
2013/09/16
Committee: IMCO
Amendment 237 #
Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 283 #
Proposal for a regulation
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.
2013/09/16
Committee: IMCO