4 Amendments of Roberta ANGELILLI 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 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.