Medical devices

Are you planning a study?

Feel free to request our
planner for clinical trials
or our
planner for non-interventional (observational) studies.

Benefit from the expertise of our Medical Device Group (MDG) and from our concrete recommendations on how to evaluate clinical data and how to implement the specific requirements of clinical trials with medical devices of all classes in accordance with national and international regulations:

  • Directive 93 / 42 / EEC concerning medical devices
  • Directive 90 / 385 / EEC relating to active implantable medical devices
  • Directive 98 / 79 / EC on in vitro diagnostics

Save your own resources and take advantage of our services:

  • scientific and medical advice
  • clinical trials in the context of
    • clinical evaluation
    • post-market clinical follow-up
  • Studies in the context of post-market surveillance
    • non-interventional (observational) studies for market investigations
    • registries
  • medical device vigilance

Please find further information about our complete clinical research service in the section Service.

Useful links related to medical devices:

  BfArM

  BMG

  DIMDI

  EC Europe EU

  Eucomed

  GHTF

  NBOG

  PEI