Activities of Alda SOUSA related to 2012/0266(COD)
Plenary speeches (1)
In vitro diagnostic medical devices - Medical devices (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 PDF (1 MB) DOC (1 MB)
Amendments (12)
Amendment 491 #
Proposal for a regulation
Article 30 – paragraph 4 a (new)
Article 30 – paragraph 4 a (new)
4a. The annual assessment of notified bodies as provided for in Article 35(3) shall include verification of the compliance of the subcontractor(s) or the subsidiary(ies) of notified bodies according to the requirements set out in Annex VI.
Amendment 494 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least two experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies and free of conflicts of interest with the applicant conformity assessment body. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who shall lead the joint assessment team.
Amendment 504 #
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly, and shall also add the information relating to the notification of the notified body to the electronic system referred to in Article 27(2).
Amendment 510 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI, including an assessment of whether its subcontractor(s) and subsidiary(ies) satisfy these requirements. This assessment shall include an on-site visit to each notified body.
Amendment 514 #
Proposal for a regulation
Article 35 – paragraph 4
Article 35 – paragraph 4
4. Three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body, or a subsidiary or subcontractor of a notified body, with the requirements set out in Annex VI.
Amendment 747 #
Proposal for a regulation
Article 83 – paragraph 1
Article 83 – paragraph 1
The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers for specific types ofmedical devices to gather post- market experience related to the use of such devices. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices and to the traceability of such devices.
Amendment 763 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – introductory part
Annex 1 – part II – point 7 – point 7.4 – introductory part
7.4. The devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device. Special attention shall be given to shazardous substances. Substances. which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 , and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) . shall be phased out within 5 years from the entry into force of this Regulation, unless no safer alternative substances are available. In the case that no safer alternatives exist, the medical device shall be labelled and the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, the technical documentation and, within the instructions for use, information on residual risks for patient groups and, if applicable, on appropriate precautionary measures. Devices containing substances having endocrine disrupting properties that come into contact with the body of patients and for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) , or are known or presumed endocrine disruptors pursuant to Commission Recommendation (2013/.../EU) on criteria for the identification of Endocrine Disrupters, shall be phased out within 5 years from the entry into force of this Regulation, unless no safer alternative substances are available. In the case that no safer alternatives exist, the medical device shall be labelled and the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, the technical documentation and, within the instructions for use, information on residual risks for patient groups and, if applicable, on appropriate precautionary measures.
Amendment 767 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
contain, in a concentration of 0.1% by mass of the plasticised material or above, phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, these devices shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women,, these substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates, phased out within 5 years from the entry into force of this Regulation, unless no safer alternatives are available. In the case that no safer alternatives exist, the medical devices shall be labelled and the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, phthalates shall be banned as of 1st January 2017.
Amendment 810 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 1
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 1
In particular, it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified.
Amendment 816 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.3
Annex 6 – point 3 – point 3.1 – point 3.1.3
3.1.3. The notified body shall clearly document the extent and the limits of the duties, responsibilities and authorities in relation of the personnel, including any subcontractors and subsidiaries, involved in conformity assessment activities and inform the personnel concerned about it.
Amendment 819 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.2 – paragraph 1
Annex 6 – point 3 – point 3.2 – point 3.2.2 – paragraph 1
Specific qualification criteria shall be defined for the assessment of biocompatibility aspects, safety, clinical evaluation and the different types of sterilisation processes.
Amendment 829 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 4 a (new)
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 4 a (new)
- appropriate knowledge and experience of clinical evaluation;