3 Amendments of Andrés PERELLÓ RODRÍGUEZ related to 2012/0267(COD)
Amendment 156 #
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority or medical association or institution, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authoritye applicant. They shall cooperate with thae competent authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
Amendment 158 #
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. 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.
Amendment 342 #
Proposal for a regulation
Article 83 – paragraph 1
Article 83 – paragraph 1
The Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The dissuasive nature of the penalty shall be determined in relation to the financial benefit obtained as a result of the infringement. The Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.