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A successful clinical investigation for Medical Device Regulation EU 2017/745 (MDR) is one that generates scientifically valid clinical data, reaches medically and scientifically sound study conclusions and is completed within planned time frames. This means that sponsors,

investigators, clinical monitors and others involved with the clinical investigation, need to fully understand, and comply with applicable regulatory requirements, standards and guidance documents. In addition, they should:

  • ensure that the clinical investigation process is in conformity with BS EN ISO 14155:2020

  • ensure the involvement of qualified personnel in the planning and conduct of the clinical investigation

  • ensure that appropriate QMS principles are followed throughout the clinical investigation process,

  • including the development of relevant SOPs and control of clinical investigation-related documents

  • ensure that an appropriate, compliant study design is developed

  • carefully select clinical study sites based on factors that are important for the study, such as subject recruitment rate, resources and knowledge of GCPs, and not solely related to the presence of a KOL

  • avoid underestimating the knowledge, qualified resources and activities needed to successfully

  • complete a medical device clinical investigation

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