Activities of Andrés PERELLÓ RODRÍGUEZ related to 2012/0266(COD)
Plenary speeches (1)
In vitro diagnostic medical devices - Medical devices (debate)
Amendments (6)
Amendment 312 #
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 a 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 319 #
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 453 #
Proposal for a regulation
Article 26 – title
Article 26 – title
Summary of safety and clinical performance report
Amendment 460 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary offull safety and clinical performance report, including the results of the clinical research and assessment. It shall be written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body.
Amendment 478 #
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to the Agency, notified bodies, economic operators, sponsors, healthcare professionals and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 750 #
Proposal for a regulation
Article 87 – paragraph 1
Article 87 – 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 the Regulation] and shall notify it without delay of any subsequent amendment affecting them.