2 Amendments of Cristina GUTIÉRREZ-CORTINES related to 2012/0266(COD)
Amendment 320 #
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
10a. Manufacturers of medical devices must be covered by an insurance policy or equivalent financial guarantee to meet claims for health damage arising from unsafe medical devices.
Amendment 321 #
Proposal for a regulation
Article 8 – paragraph 10 b (new)
Article 8 – paragraph 10 b (new)
10b. Manufacturers shall bear the cost to the health system of treatment, operations and diagnostic procedures practiced on patients as a result of defects in or malfunctioning of health devices detected by the health authorities or the manufacturers themselves. They shall also bear the cost of withdrawing, repairing or replacing the products involved in these situations.