21 Amendments of Anja WEISGERBER related to 2012/0266(COD)
Amendment 115 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 116 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a declaration of conformity by the manufacturer or importer, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 117 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 24 and Article 11(3) respectively11(3).
Amendment 118 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and, within their respective area of activity, make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 139 #
Proposal for a regulation
Article 24 – paragraph 8 – point e b (new)
Article 24 – paragraph 8 – point e b (new)
(eb) compatibility with medical device identification systems already on the market.
Amendment 161 #
Proposal for a regulation
Recital 13
Recital 13
(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and, manufacture and conformity assessment of medical devices, the manufacturers should take special care when using nanoparticles that can be released to the human bodyintended for release in the human body, they should have to meet additional basic requirements in respect of the nanomaterials in question and their use in the relevant device group, and those devices should be subject to the most severe conformity assessment procedure.
Amendment 276 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State oand after con its own initiativesultating the MDCG and the undertaking concerned, by means of implementing acts, determine whether or not a specific novel product, or new category or group of products, falls within the definitions of 'medical device' or 'accessory to a medical device'. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). This paragraph shall not apply to products already authorised.
Amendment 278 #
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. Following the consultation procedure provided for in paragraph 1, the Commission shall draw up guidelines in order to ensure that there is a science- based procedure for the categorisation of devices.
Amendment 331 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 332 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a manufacturer’s or importer’s declaration of conformity, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 333 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 24 and Article 11(3) respectively11(3).
Amendment 337 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure, within their field of operations, that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 445 #
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) compatibility with identification systems for medical devices already on the market.
Amendment 561 #
Proposal for a regulation
Article 44
Article 44
Amendment 718 #
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
Amendment 724 #
Proposal for a regulation
Article 80 – paragraph 1 – point c
Article 80 – paragraph 1 – point c
(c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;.
Amendment 726 #
Proposal for a regulation
Article 80 – paragraph 1 – point e
Article 80 – paragraph 1 – point e
Amendment 728 #
Proposal for a regulation
Article 80 – paragraph 1 – point f
Article 80 – paragraph 1 – point f
Amendment 730 #
Proposal for a regulation
Article 80 – paragraph 1 – point f a (new)
Article 80 – paragraph 1 – point f a (new)
Amendment 778 #
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
Annex 1 – part II – point 9 – point 9.2
9.2. Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are intended to be absorbed by or dispersed in the human body in order to achieve the desired effect shall comply, by analogy, with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
Amendment 849 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user's body when the device is used within its intended purposedeliberately intended to be released into the body are in class III.