8 Amendments of Linda McAVAN related to 2012/0266(COD)
Amendment 146 #
Proposal for a regulation
Citation 5 a (new)
Citation 5 a (new)
Having regard to the 2010 Directive on Prevention from Sharps Injuries, which guarantees safety not just for patients but also for users of sharp needles.
Amendment 158 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
Amendment 413 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device. The implant card shall also be made available in an electronic format, and Member States shall ensure that hospitals and clinics keep an electronic version on record, so that it can be easily forwarded at the request of a patient.
Amendment 420 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 – point b a (new)
Article 16 – paragraph 2 – subparagraph 1 – point b a (new)
(ba) Information about the special characteristics of the device and any potential adverse effects
Amendment 422 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 – point c a (new)
Article 16 – paragraph 2 – subparagraph 1 – point c a (new)
(ca) A space for signature for the surgeon and the patient, so that the card can be used as a consent form for the operation.
Amendment 872 #
Proposal for a regulation
Annex 8 – point 4 – point 4.4 – paragraph 3
Annex 8 – point 4 – point 4.4 – paragraph 3
The notified body shall provide the manufacturer with an inspection report which shall include, if applicable, the result of the sample check. This report shall be made public.
Amendment 905 #
Proposal for a regulation
Annex 15 – point 3 a (new)
Annex 15 – point 3 a (new)
3 a. Chemical peels
Amendment 907 #
Proposal for a regulation
Annex 15 – point 5
Annex 15 – point 5
5. Invasive lLaser equipment intended to be used on the human body;