3 Amendments of Frédérique RIES related to 2012/0266(COD)
Amendment 748 #
Proposal for a regulation
Article 83 – paragraph 1
Article 83 – paragraph 1
The Commission and the Member States shall take all appropriate measures to encourage the establishment of coordinated and harmonized registers for specific types of devices to gather post- market experience related to the use of such devices. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices.
Amendment 845 #
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 2
Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 2
– are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in class III, with the exception of sutures and staples.
Amendment 847 #
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 8
Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 8
– are spinal disc replacement implants and implantable devices that come into contact with the spinal columnrd, in which case they are in class III.