3 Amendments of Claudiu Ciprian TĂNĂSESCU related to 2012/0266(COD)
Amendment 180 #
Proposal for a regulation
Recital 35
Recital 35
(35) Transparency and better, together with clear and non-promotional information are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 270 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 43
Article 2 – paragraph 1 – subparagraph 1 – point 43
(43) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, any inadequacy in the information supplied by the manufacturer and any unexpected undesirable side- effect;, including the wrongful use of the device.
Amendment 654 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
2. The national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the incident, as well as they shall take into account patients' opinions.