Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Course Time 29 Min
$75 Per person


Maria Donawa
Maria Donawa
Member of the Board, EAAR, President, Donawa Lifescience, Italy
Maria E. Donawa, MD is President, Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six years with the US FDA, in the area of medical device regulation. Donawa Lifescience provides US and European quality system, regulatory and clinical services to life science companies worldwide.

Dr Donawa is an active member of the ISO study group responsible for the development and revision of ISO 14155, the international standard for medical device clinical investigations.

She is also a stakeholder observer to the Clinical Investigation and Evaluation (CIE) Working Group. The CIE assists the Medical Device Coordination Group (MDCG) on issues relating to clinical investigation and evaluation of medical devices in accordance with the MDR.

Dr Donawa has US degrees in pharmacy and medicine, with post-doctoral specialization in clinical and anatomical pathology.


The MDR includes very specific requirements concerning the evaluation of risks, residual risks, and the resulting benefit/risk ratio alongside those for the conduct of a clinical investigation being conducted for conformity assessment purposes. In addition, EN ISO 14155:2020 includes expanded requirements for risk management during the planning of a clinical investigation, and a new informative Annex indicates the risk management activities that should be carried out before and during the clinical investigation. Although the need to address and evaluate risks in a clinical investigation is not new, the requirements have become more specific under the MDR. This presentation will discuss the key MDR requirements for the interface between clinical investigation and risk management, the expanded risk management activities and new guidance in EN ISO 14155, and advice on how to ensure these activities are aligned and managed in a coordinated manner.

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