Impeto Médical sas Directive 93/42/EEC Directive 93/42/EEC - Conception

09 Le Snitem et la formation valoriser le secteur du dispositif médical des LAP et des LAD étaient contraires à la directive 93/42 relative.

16 sept. 2021 La loi de financement de la sécurité sociale (LFSS) est très impactante pour les entreprises du secteur des dispositifs médicaux. Elle fixe ...

médico-économique une place nouvelle dans la régulation du système de santé. et du dispositif médical elle travaille en relation.

Harmonised standards under 93/42/EEC - Medical devices directive with relevance to COVID-19 2 Table indicating recognition of international standards under the legal systems of the member jurisdictions of the International Medical Device Regulators Forum (IMDRF) – based on information provided in 2019 updated with regard to EU

Commission communication in the framework of the implementation of the Council Directive 93/ 42/EEC concer ning medical devices (Publication of titles and references of har monised standards under Union har monisation legislation) (Text with EEA relevance) (2017/C 389/03) ESO (1) Reference and title of the standard

on the basis of the requirements of Directive 93/42/EEC and applicable reference standards The outcome of the examination of the technical documentation will be formally communicated to the organisation; any nonconformities found will have to be resolved by the organisation before the certification process can continue

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN communities Having regard to the Treaty establishing the European Economic Community and in particular Article 100a thereof Having regard to the proposal from the Commission (1) In co-operation with the European Parliament (2)

4) Guidance documents for Medical Device Directive 93/42/EEC Harmonized European Standards available for a fee They areconsidered the ‘state of the art’ and are considered ‘not mandatory’ but in reality you will be unable to cemark a device without the use of- harmonized EU standards

Medical Device Directive 93/42/EEC MDD (and supplementary Directive 2007/47/EC) Medical devices must be classified according to potential risks associated Class I Low/medium risk - Class Im: Measuring devices -Class Is: Sterile devices Class IIa Medium risk Class IIb Medium/High risk Class III High risk Eurofins Product Testing Italy is

Medical Device Directive 93/42/EEC and supplementary Directive 2007/47/EC (MDD) Medical devices must be classified according to potential risks associated as follow: Class I Low/medium risk - Class Im: Measuring devices - Class Is: Sterile devices Class IIa Medium risk Class IIb Medium/High risk Class III High risk Certification services

To take into account some medical conditions the Directive excludes straws that fall within the scope of Directive 90/385/EEC3 on active implantable medical devices or Directive 93/42/EEC4 relating to medical devices and their accessories5 For applications not covered