3 Amendments of Sari ESSAYAH related to 2012/0266(COD)
Amendment 192 #
Proposal for a regulation
Recital 44
Recital 44
(44) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement of a notified body should be compulsory, with medical devices in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market. Where product classifications are made stricter, an adequate transition period must be permitted. Particularly in the case of devices which have been on the market for decades and are reliable and problem- free, unnecessary additional testing requirements should be reduced. It would be more appropriate to allocate these resources to innovation.
Amendment 215 #
Proposal for a regulation
Recital 64
Recital 64
(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them. The role of reference laboratories should concentrate on post- market activity, so that their work also lends good support to that of the authorities. In the position of reference laboratories, the emphasis should be on independence and clear definition of duties. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Amendment 220 #
Proposal for a regulation
Recital 68
Recital 68
(68) To allow economic operators, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements to be taken for its proper application. It is particularly important that by the date of application, a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market. Notified bodies are economic operators, and they may be regarded as requiring concentration. It is important that notified bodies should be able to cooperate and that concentration of notified bodies should not make it more difficult for SMEs to set up in business.