13 Amendments of Christel SCHALDEMOSE related to 2012/0266(COD)
Amendment 210 #
Proposal for a regulation
Recital 57 a (new)
Recital 57 a (new)
(57a) Member States are invited to set and enforce serious penalties for manufacturers that commit fraud and cheat with regard to medical devices. Those penalties should be at least as large as the revenue gains from fraud or cheating. Penalties may include imprisonment.
Amendment 386 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation. This requirement shall also apply to hospitals and other health institutions as defined in Article 2(1)(24).
Amendment 472 #
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2a. the electronic system on registration of subsidiaries and subcontracting referred to in Article 29a.
Amendment 483 #
Proposal for a regulation
Article 28 – paragraph 7
Article 28 – paragraph 7
7. The ultimate responsibility for the notified bodies and the national authority responsible for notified bodies lies with the Member State in which they are located. The Member State is required to check that the designated national authority responsible for notified bodies performs its work on the assessment, designation and notification of conformity assessment bodies and for the monitoring of the notified bodies properly and that the designated national authority responsible for notified bodies works impartially and objectively. Member States shall provide the Commission and the other Member States with information on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto.
Amendment 485 #
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29 a The notified body shall publish a list of its staff responsible for the conformity assessment and certification of medical devices. This list shall at least contain the qualifications, CV and declaration of conflicts of interest for each member of staff. The list shall be sent to the national authority responsible for notified bodies which shall check that the staff satisfies the rules of this Regulation. The list shall also be sent to the Commission.
Amendment 486 #
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29 a Electronic system on registration of subsidiaries and subcontracting 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on subcontractors and subsidiaries, as well as on the specific tasks for which they are responsible. 2. Before subcontracting to public entities or external experts can effectively take place, the notified body which intends to subcontract specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, shall register their name(s) together with their specific tasks. 3. Within one week of any change occurring in relation to the information referred to in paragraph 1, the relevant economic operator shall update the data in the electronic system. 4. The data contained in the electronic system shall be accessible to the public.
Amendment 499 #
Proposal for a regulation
Article 33 a (new)
Article 33 a (new)
Article 33 a The Commission shall adopt guidelines on the minimum time which the conformity assessment process should last and give indications on the average time of each type of medical devices in the conformity assessment process.
Amendment 509 #
Proposal for a regulation
Article 35 a (new)
Article 35 a (new)
Article 35 a Member States shall ensure they have a system of sanctions in place in case notified bodies do not fulfil the minimum requirements. This system should be transparent and proportionate to the nature and level of the non-compliance.
Amendment 765 #
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 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 andor 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 disrupters pursuant to Commission Recommendation (2013/.../EU) on criteria for the identification of endocrine disrupters.
Amendment 766 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – introductory part
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – introductory part
Amendment 768 #
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
shall not contain, in a concentration of 0.1% by mass of the plasticised material or above, phthalator above by mass per homogeneous material, substances 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, or substances identified as endocrine disrupters pursuant to the first subparagraph, unless the manufacturer can show that there are no suitable safer substances or devices without these substances. In case the manufacturer can show that there are no suitable safer substances or devices without these substances, 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, tsubstances which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B or substances identified as endocrine disrupters. 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. (Linked to the amendment by the same authors to the first eight words of this subparagraphOr. en (AT4AM aberration).)
Amendment 769 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.6
Annex 1 – part II – point 7 – point 7.6
7.6. The devices shall be designed and manufactured in such a way as to reduce to a minimum the risks linked to the size and the properties of particles used. Special care shall be applied when devices contain or consist of nanomaterial that can be released into the patient's or user's body. The manufacturer shall provide specific evidence that the use of the nanomaterial complies with the general safety and performance requirements within the technical documentation. The specific evidence has to be shown to respond to the specific characteristics of the nanomaterial. The manufacturer shall also provide within the instructions for use, information on residual risks for patients and, if applicable, on appropriate precautionary measures.
Amendment 862 #
Proposal for a regulation
Annex 8 – point 3 – point 3.4
Annex 8 – point 3 – point 3.4
3.4. The manufacturer shall inform the notified body which approved the quality mIn cooperation the notified body, the manufacturer shall define which chanagement system of any plan for substantial changes to the quality management system or the product-range covereds are to be characterised as substantial and should be reported to the notified body. The notified body shall assesconduct audits theo changes proposed and verify whether after these changes the quality management system still meets the requirements referred to in Section 3.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the audit and a reasoned assessmenteck that the manufacturer's descriptions of substantial changes are adequate and that the manufacturer complies with these. The approval of any substantial change to the quality management system or the product-range covered shall take the form of a supplement to the EU full quality assurance certificate.