BETA

6 Amendments of Salvatore TATARELLA related to 2012/0266(COD)

Amendment 291 #
Proposal for a regulation
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).
2013/05/14
Committee: ENVI
Amendment 564 #
Proposal for a regulation
Article 44
[...]deleted
2013/05/14
Committee: ENVI
Amendment 758 #
Proposal for a regulation
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;
2013/05/14
Committee: ENVI
Amendment 777 #
Proposal for a regulation
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 absorbed by or dispersed in the human body shall comply, by analogy, with the relevant requirements laid down in Annex I to Directive 2001/83/EC.deleted
2013/05/14
Committee: ENVI
Amendment 857 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.9
6.9. Rule 21 Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in class III.deleted
2013/05/14
Committee: ENVI
Amendment 861 #
Proposal for a regulation
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.
2013/05/14
Committee: ENVI