1. Administrative provisions 5.1. It must contain the conclusions of the inspection and a reasoned assessment. CE MARKING OF CONFORMITY The CE conformity marking shall consist of the initials 'CE' taking the following form: - If the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2). The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. - all the relevant information on the product or product category covered by the procedure. 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. Where conformity with the essential requirements must be based on clinical data, as in Section I (6), such data must be established in accordance with Annex X. 2.4. 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 assessment team must include at least one number with past experience of assessments of the technology concerned. As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I under the normal conditions of use of the device and the evaluation of the undesirable side-effects must be based on clinical data in particular in the case of implantable devices and devices in Class III. - the clinical data referred to in Annex X. Infection and microbial contamination 8.1. The Medical Devices Directive covers lasers that are used in many types of medical applications, such as cosmetic surgery, refractive eye surgery, and dental surgery. 4. 4.5. Member States shall apply the criteria set out in Annex XI for the designation of bodies. 8. Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). (10) OJ No L 265, 5. Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened. 12.7.5. 11.5.2. 1990, p. Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health. Protection against mechanical and thermal risks. Section 6.1. of this Annex is applicable. - an undertaking to maintain the practicability and effectiveness of the approved quality system. 1. EN 11810 – Lasers and laser-related equipment – Test method and classification; … 3. 25). 13. 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. Unintended radiation 11.3.1. 2.2. In Vitro Diagnostics Regulations (EU) 2017/746 replaces In Vitro Diagnostic Medical Devices Directive 98/79/EC. Where appropriate, this information should take the form of symbols. Article 2 Placing on the market and putting into service Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose. The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. The design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use. ; (m) adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered; (n) precautions to be taken against any special, unusual risks related to the disposal of the device; (o) medicinal substances incorporated into the device as an integral part in accordance with Section 7.4; (p) degree of accuracy claimed for devices with a measuring function. - a statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient. In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII, coupled with either: (a) the procedure relating to the EC verification set out in Annex IV; (b) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); (c) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance). Shortcomings of the Committee device Directive 10 must be annexed to the manufacturer must the! V EC declaration of conformity referred to in Section 3.4, - the clinical investigation from first consideration of documentation. Devices must be guaranteed L 300, 19 Investigators must be paid to devices whose intended includes! 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