9 Amendments of Sirpa PIETIKÄINEN related to 2012/0266(COD)
Amendment 88 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) With devices that consist of more than one implantable part, such as hip implants, compatibility of the parts of different manufacturers should be ensured in order to avoid the replacement of the functional part of the device and thus unnecessary risks and inconvenience for patients. The Commission should investigate the need for further measures to ensure the compatibility of the equivalent parts of hip implants from different manufacturers, bearing in mind that the hip operations are most often made on older people for whom the health risks of operations are higher.
Amendment 128 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be translated intoissued in one of the official Union language or languages required by the Member State(s) in which the device is made availables.
Amendment 132 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without significantly changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. For devices composed of more than one implantable part, it shall also be ensured that the article does not require the replacement of the whole device due to incompatibility with the functioning part of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States.
Amendment 163 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) With devices that consist of more than one implantable part, such as hip implants, compatibility of the parts of different manufacturers should be ensured in order to avoid the replacement of the functional part of the device and thus unnecessary risks and inconvenience for patients. The Commission should investigate the need for further measures to ensure the compatibility of the equivalent parts of hip implants from different manufacturers, bearing in mind that the hip operations are most often made on older people for whom the health risks of operations are higher.
Amendment 189 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.1 – point b a (new)
Annex 1 – part II – point 7 – point 7.1 – point b a (new)
(ba) the physical compatibility between the different manufacturers’ parts of the devices which consist of more than one implantable part;
Amendment 190 #
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 propertiesshall be phased out within 8 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 manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, 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. 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) and in accordance with the endocrine disrupting substances’ criteria set out in the report of the Endocrine Disrupters Expert Advisory Group shall be phased out within 8 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 manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, 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 191 #
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 phased out within 8 years from the entry into force of this Regulation, unless no safer alternatives are available. In the case that no safer alternatives exist, 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 should be banned as of 1st January 2020.
Amendment 433 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without significantly changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. For devices composed of more than one implantable part, it shall also be ensured that the article does not require the replacement of the whole device due to incompatibility with the functioning part of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States.
Amendment 761 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.1 – point b a (new)
Annex 1 – part II – point 7 – point 7.1 – point b a (new)
(b a) the physical compatibility between the different manufacturers' parts of the devices which consist of more than one implantable part;