10 Amendments of Paolo BARTOLOZZI related to 2012/0266(COD)
Amendment 235 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1 a (new)
The medical devices produced by the various manufacturers and intended for use with a coupling or connection system for the supply of fluids shall be type approved/standardised in order to ensure that patients with chronic conditions receive appropriate treatment; otherwise it would be impossible to ensure that the devices are used as intended.
Amendment 242 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 2 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 2 a (new)
(2a) The accessories to medical devices produced by the various manufacturers shall be type approved/standardised in order to ensure that, at all times and in all places, they perform as specified and are used as intended when treating patients.
Amendment 291 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post- market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
Amendment 564 #
Proposal for a regulation
Article 44
Article 44
Amendment 758 #
Proposal for a regulation
Article 97 – paragraph 3 – subparagraph 1 – point a
Article 97 – paragraph 3 – subparagraph 1 – point a
(a) Article 25(2) and (3) and Article 45(4) shall apply from [18 months after date of application referred to in paragraph 2] provided that the relevant electronic system has been validated and in operation;
Amendment 777 #
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
Annex 1 – part II – point 9 – point 9.2
Amendment 780 #
Proposal for a regulation
Annex 1 – part II – point 11 – point 11.1 a (new)
Annex 1 – part II – point 11 – point 11.1 a (new)
11.1a. Coupling systems shall be subject to uniform type approval procedures in order to ensure that the specified performance of such devices is not impaired. Not requiring type approval of coupling systems undermines the guarantees that such devices will be used for their intended purpose, as well as patient rights.
Amendment 797 #
Proposal for a regulation
Annex 2 – paragraph 1 – point 6 – point 6.2 – point e
Annex 2 – paragraph 1 – point 6 – point 6.2 – point e
(e) If the device is to be connected to other device(s) by means of a coupling system in order to operate as intended, a description of this combination including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer. This coupling system shall be type approved in order to ensure that it is used as intended and that the patient receives appropriate treatment.
Amendment 857 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.9
Annex 7 – part III – point 6 – point 6.9
Amendment 861 #
Proposal for a regulation
Annex 8 – point 3 – point 3.3 – point a
Annex 8 – point 3 – point 3.3 – point a
(a) The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 3.2. Unless duly substantiated, iIt shall presume that quality management systems which satisfy the relevant harmonised standards or CTS conform to the requirements covered by the standards or CTSreferred to in Section 3.2.