6 Amendments of Elisabetta GARDINI related to 2012/0266(COD)
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 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.