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Home arrow Eurom Committees arrow Eurom VI

Eurom VI - Medical Technology PDF Print E-mail
National Associations which are members of EUROM VI represent European small and medium enterprises involved in medical devices for :

  • - surgery ( including dental)
    - anesthesia, respiration and inhalation,
    - operating theatre,
    - gas supply,
    - sterilization, disinfection,
    - internal and external orthopaedics,
    - optomedical and ophthalmology area,
    - rehabilitation and handicaps fields,
    - infusion and transfusion.


Objectives:

  • - to represent European Medical Technology Industry;
    - to promote cooperation between members but also with other European organizations;
    - to encourage worldwide trade by being involved in harmonization of legislation, standardization, mutual recognition and certification procedures;
    - to be a partner on works with UE Commission and Standardization Bodies;
    - to defend European Industry views on international activities.


Technological and Regulatory requirements:

By merging the varions types of techniques and by making constant effort of
investment in research and development the Medical Industry has provided
notable innovations for the benefit of patients:

  • - less invasive surgery
    - laser applications
    - ambulatory care
    - resuscitation, monitoring and intensive care
    - sophisticated implants
    - technical aids (for disabled persons)

Due to the specific use of medical equipment on patients, safety and prevention of risky effects on the body, particular regulations have to be observed in three directions:

  • - quality and safety policy
    - sanitary policy
    - medical efficiency

Therefore, CE marking becomes the authorized procedure to put a medical device on the market but further procedures have to be fulfilled to meet requirements of social, budgetary and health systems.

Download:
PDF Flyer: The meaning of CE marking for medical devices (PDF, 131 KB)

PDF Recast - EUROM VI Comments and Proposals (PDF, 314 KB)
PDF Recast - Joint Medical Device Industry Position Paper (PDF, 67 KB)
PDF Recast - Joint Medical Device Industry Press Release (PDF, 44 KB)

PDF report tc 98-99 (PDF, 18 KB)
PDF report tc 98-99 meetings carl (PDF, 18 KB)
PDF ISM 2000 28off aami human factor (PDF, 78 KB)

ZIP Workpaper 2001 (ZIP, 290 KB)
ZIP Workpaper 2002 (ZIP, 620 KB)
ZIP Workpaper 2003 (ZIP, 1,3 MB)
ZIP Workpaper 2004 (ZIP, 2,2 MB)
ZIP Workpaper 2005 (ZIP, 80 KB)