5 Amendments of Marina YANNAKOUDAKIS related to 2012/0267(COD)
Amendment 83 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In the case of urgent or unmet medical needs for patients, such as emerging pathogens and rare diseases, single health institutions should have the possibility to manufacture, modify and use devices in-house and therefore address, within a non-commercial and flexible framework, specific needs which can not be met by an available CE- marked device.
Amendment 138 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution’s single quality management system, and the health institution is compliant withaccredited to standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 141 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Article 4 – paragraph 5 – subparagraph 2
Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply withbe exempt from the requirements of this Regulation. However, the provis, with the exception of Article 59(4), where the following conditions aregarding met; (a) the recipient patient or patient group’s specific needs can not be met by an available CE -marking set out in Article 16 and the obligationsed device; (b) the health institution is accredited to EN ISO standard 15189 quality management system, or any other equivalent recognised standard; (c) the health institution provides their competent authority referred to in Articles 21 to 25 shall not apply to those devices6 with a list of such devices, which shall include a justification of their manufacturing or modification, in particular, where similar devices have been made available on the market. This information shall be updated yearly, and shall be made public.
Amendment 142 #
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
5a. Member States shall retain the right to restrict the in-house manufacture and use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation, and may also make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 312 #
Proposal for a regulation
Article 60 – paragraph 1 – point f a (new)
Article 60 – paragraph 1 – point f a (new)
(f a) the reports by competent authorities on serious incidents and field safety corrective actions taken within Health Institutions involving devices referred to in Article 4(4)