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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
Read more...

In-House Workshops
The "NEW CE" mark
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EVENTS
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8. Medical Device Networking Meeting
Hanover, April 27, 2017




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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Consulting: Clinical Evaluation


The revision of the Medical Device Directives with the directive 2007/47/EC now requires even for the lowest risk class Medical Devices - manufacturer to establish clinical data. The Clinical evaluation of Clinical data may be derived from a literature review, clinical trials or a combination of both. The data should follow a certain format. Clinical trials are regulated nationally since the directive outlines the requirements but not the details for clinical trials. This means that the detailed rules for clinical trials are not harmonized in Europe. 

MDSS will support you with all aspects of the clinical evaluation of your products. Please contact us for details:
  • Planning and preparation according to the directives and guidelines

  • Clinical Evaluation Plan

  • Literature research and survey

  • Provision of clinical expertise and expert opinion

  • Clinical Closure report

  • Correspondence and notification with:
    • Local Ethics Comittee

    • The Federal Office for Radiation Protection (if necessary)

    • The Competent Authorities

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