Activities of Ashley FOX related to 2012/0267(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
Amendments (2)
Amendment 58 #
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'sa 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 hHealth institutions submithall provide to their competent authority a list of such devices which shave been manufactured and used on their territory and mayll include justification of their use, in particular where equivalent devices have been made available on the market. This information shall be made public. Member States may also make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 60 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Article 4 – paragraph 5 – subparagraph 2