93 Official Journal of the European Communities usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the MemberStates relating to analytical, pharmaco-toxicological and clinical standards and protocols.
in respect of the testing of proprietary medicinal products('); other and requirements essential the Whereas requirements set out in the Annexes to this Directive, including any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a wayas to take accountof technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety; in accordance with the principles set out in Whereas, the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization (7), rules regarding the design and .
competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State -4,|The Commissionshall, no later than five years from concerned,of individual devices for which the procedures the date of implementation of this Directive, submit a referred to in paragraphs 1 to 6 have not been carried report to the Council on the operation of the provisions out and the use of which is in the interest of protection referred to in Article 10 (1), Article 15 (1), in particular of health, in respect of Class I and Class Ila devices, and on the operation of the.
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
In the case of devices which have been subjected to EEC pattern approval in accordance with Directive 76/764/EEC, Member States shall accept their being placed on the market and put into service during the period up to 30 June 2004.