If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 65/65/EEC. '; 5. the following is added to Article 14: 'In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.' Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11. In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1: 'If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC (*) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive. - are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I. 11. This information comprises the details on the label and the data in the instructions for use. 6. 4. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly and that the production conforms to the requirements of the Directive which apply to it. Requirements for medical devices connected to or equipped with an energy source. Application of the classification rules shall be governed by the intended purpose of the devices. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. ); (j) in the case of devices emitting radiation for medical purposes, details of the nature, type, intensity and distribution of this radiation. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The manufacturer must present the manufactured products in the form of homogeneous batches. - investigation, replacement or modification of the anatomy or of a physiological process. Under the quality system, each product or a representative sample of each batch is examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests are carried out to ensure that the products conform to the type described in the EC type-examination certificate and fulfil the provisions of this Directive which apply to them. For the purposes of this Directive, reference to harmonized standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Communities. The objectives of clinical investigation are: - to verify that, under normal conditions of use, the performance of the devices conform to those referred to in Section 3 of Annex I, and. The design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use. The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and … 1.6. It must also have access to the equipment necessary for the verifications required. Additional rules applicable to active devices 3.1. The clinical investigations must be conducted in accordance with the provisions of Annex X. The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure. Directive as last amended by Directive 84/467/Euratom (OJ No L 265, 5. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible. In addition, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Annex V, Sections 3 and 4. The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. The manufacturer lodges an application for assessment of his quality system with a notified body. Schlagwort: Medizinprodukterichtlinie 93/42/EWG (Medical Device Directive MDD) Die Medizinprodukterichtlinie (Richtlinie 93/42/EWG des Rates), englisch Medical Device Directive, oft als MDD oder 93/42/EWG bezeichnet, ist eine von drei europäischen Richtlinien für Medizinprodukte. Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device. The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. Placing on the market and putting into service. The approval of the cantonal Ethics … The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. - to replace an epithelial surface or the surface of the eye. 4. 6. 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