Activities of Jean LAMBERT related to 2012/0266(COD)
Shadow opinions (1)
OPINION 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
Amendments (4)
Amendment 55 #
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 arehave been 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 56 #
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 57 #
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. Where 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.
Amendment 58 #
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 nanomaterials that can be released into the patient's or user's body. The manufacturer shall provide specific evidence that the use of nanomaterials complies with the general safety and performance requirements within the technical documentation and, within the instructions for use, information on residual risks for patients and, if applicable, on appropriate precautionary measures.