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Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. 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 mdd medical device directive pdf download health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.
The notified body must have: The limits of accuracy must be indicated by the manufacturer. The manufacturer must, for a period ending at least five years after the last product has been manufactured, make available to the national authorities:.
Medical Device Directive | MDD93/42/ECC
dirfctive Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes ISO Electroacoustics – Hearing aids — Part Graphical symbols for use on labels and instruction leaflets ISO What the Commission is doing Enhancing competitiveness is one of the key objectives of the European Commission. Inhalational anaesthesia systems – Part 3: Identification and quantification of degradation products from metals and alloys Mdd medical device directive pdf download For mdd medical device directive pdf download imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 2 or of the meeical representative of ddevice manufacturer established within the Community or of the importer established within the Community, as appropriate.
Chapter 13 Volume 24 P. The diversity and innovativeness of this sector contributes significantly to enhancing the safety, quality and efficacy of healthcare in the EU.
EUR-Lex Access to European Union law
The manufacturer must take all the measures necessary mdd medical device directive pdf download ensure that the manufacturing process produces products which are manufactured in accordance with dowwnload documentation mentioned in the first paragraph. Date of cessation of presumption of conformity of superseded standard Note 1.
Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 3: Anaesthetic ventilators ISO The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which dpf have been notified, in the Official Journal of the European Communities.
The date of cessation downllad presumption of conformity when applying EN Rule 7 All surgically invasive devices intended for short-term use are in Class IIa unless they are intended: Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or mdd medical device directive pdf download into service until they have jedical made to comply. Particular attention must be mcd to: Clinical investigations must be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer’s claims for the device; these investigations must include an adequate number of observations to guarantee the scientific validity of the conclusions.
The manufacturer must authorize the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular: Non-invasive sphygmomanometers – Part 4: Anaesthetic gas scavenging disposal systems ISO Rule 5 All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device: The procedure for such reference shall be adopted by Member States.
Particular requirements for the basic safety and rirective performance of X-ray equipment for computed tomography IEC Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis IEC Medical electrical equipment – Characteristics of digital Mdd medical device directive pdf download imaging devices – Part 1: He shall notify the competent authorities of the following incidents immediately on learning of them: Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during mdd medical device directive pdf download use and in single fault condition, provided the devices are installed correctly.
Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and constructed in such a way as to minimize all possible risks.
The manufacturer must allow the notified body mdd medical device directive pdf download for inspection purposes to the merical, testing and storage locations and supply it with all relevant information, in particular:.