4.3. In the case of devices other than those referred to in the second paragraph, Member States may authorize manufacturers to commence clinical investigations, immediately after the date of notification, provided that the ethics committee concerned has delivered a favourable opinion with regard to the investigational plan. Application to devices in Class IIa In line with Article 11 (2), this Annex may apply to products in Class IIa, subject to the following exemptions: 8.1. in derogation from Sections 1 and 2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them; 8.2. in derogation from Sections 1, 2, 5 and 6, the verifications conducted by the notified body are intended to confirm the conformity of the products in Class IIa with the technical documentation referred to in Section 3 of Annex VII. The Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 11 and the specific tasks for which the bodies have been designated. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. The manufacturer lodges an application for assessment of his quality system with a notified body. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices; (e) 'device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment. Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. The manufacturer must authorize the assessment, or audit where necessary, of the effectiveness of these measures. All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa. If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instructions for use. 4. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: (i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (ii) any technical or medical reason connected with the characteristics or the performance of a device for the reasons referred to in subparagraph (i) leading to a systematic recall of devices of the same type by the manufacturer. 2. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the notified body. It shall ensure that the list is kept up to date. 6. 9.3. Construction and environmental properties. Long term Normally intended for continuous use for more than 30 days. The manufacturer must also undertake to keep available for the competent national authorities: 3.1. for custom-made devices, documentation allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive. The applicant must inform the notified body which issued the EC type-examination certificate of any significant change made to the approved product. (18) OJ No L 262, 27. However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular: - a general description of the type, including any variants planned. The Committee may examine any question connected with implementation of this Directive. In the case of devices referred to in Annex I, paragraph 7.4, the notified body shall, in view of the aspects addressed in that paragraph, consult one of the competent bodies established by the Member States in accordance with Directive 65/65/EEC before taking a decision. 11.5.2. The notified body must make available to the other notified bodies and the competent authority, on request, all relevant information concerning quality system approvals issued, refused or withdrawn. Be governed by the manufacturer for recording of X-ray diagnostic images are in Class I keep under control EU... 4 Free movement, devices intended to supply energy in the packaging for every.! 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