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Clinical Studies

MedNet as your Authorized Representative / Sponsor Representative acts as your legal entity towards the relevant European Authorities and fulfills on your behalf the obligations as required by the relevant directives and local laws of the EU member states in which the studies will be performed.

MedNet Services for clinical studies
and performance evaluations

  • fast study notifications / registrations to EU Competent Authorities with special experience in the complex German medical devices legislation
  • guidance in the language requirements in Europe
  • Severe Adverse Events (SAE) reporting to the Competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU member state
  • notification of the Competent Authorities about the end or early termination of the clinical investigation in time

Why are Clinical Studies necessary?

  • Medical devices as defined in the medical device directive MDD 93/42/EEC must comply with the essential requirements concerning the characteristics and performances under the normal conditions of use of medical devices, the evaluation of the side-effects and the acceptability of the benefit/risk ratio defined in the relevant directives of the European Community. The confirmation of the required conformity has to be based on clinical data. One option for obtaining those data is to perform a clinical study to evaluate the effectiveness and safety of the medical device by monitoring its effects on large groups of humans.

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