Translation of "dispositif pour travaux en élévation " (French → English) :

In order to maintain a high level of safety and health protection against the risk of transmitting animal spongiform encephalopathies to patients or other persons via medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable, including custom-made devices and devices intended for clinical investigation, it is necessary to update the rules laid down in Directive 2003/32/EC on the basis of the experience with the application of this Directive and to apply them also to active implantable medical devices manufactured utilising tissues of animal origin that fall within the scope of Directive 90/385/EE ...[+++]C.

In order to maintain a high level of safety and health protection against the risk of transmitting animal spongiform encephalopathies to patients or other persons via medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable, including custom-made devices and devices intended for clinical investigation, it is necessary to update the rules laid down in Directive 2003/32/EC on the basis of the experience with the application of this Directive and to apply them also to active implantable medical devices manufactured utilising tissues of animal origin that fall within the scope of Directive 90/385/EE ...[+++]C.

EUROPA - EU law and publications - EUR-Lex - EUR-Lex - 32009L0081 - EN - Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (Text with EEA relevance) - DIRECTIVE 2009/81/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL // of 13 July 2009 // on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 20 ...[+++]04/18/EC // Services referred to in Articles 2 and 15 // Services referred to in Articles 2 and 16 // Definition of certain technical specifications referred to in Article 18 // Information to be included in the notices referred to in Article 30 // Information to be included in the subcontract notices referred to in Article 52 // FEATURES CONCERNING PUBLICATION // REGISTERS - ( // Requirements relating to devices for the electronic receipt of requests to participate and tenders

(10) The Commission, in particular in the light of the proceedings conducted by its Joint Research Centre, should also provide detailed technical guidelines, definitions and procedures for the technical characteristics of identifiers and readers, test procedures, acceptance criteria and the certification model for approved test laboratories, the procurement of appropriate identifiers and readers, the application of identifiers, their reading and recovery, the codification of identifiers, a common glossary, a data dictionary and communication standards.

(10) The Commission, in particular in the light of the proceedings conducted by its Joint Research Centre, should also provide detailed technical guidelines, definitions and procedures for the technical characteristics of identifiers and readers, test procedures, acceptance criteria and the certification model for approved test laboratories, the procurement of appropriate identifiers and readers, the application of identifiers, their reading and recovery, the codification of identifiers, a common glossary, a data dictionary and communication standards.

Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be comp ...[+++]ulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;