MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them

MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them

Course Time 45 Min
$70 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.


Sponsors of clinical investigations planned to be conducted under the MDR will need to comply with a new requirement to “provide evidence that the investigation is being conducted in line with good clinical practice (GCP), for instance through internal or external inspection.” The previous MDD and AIMDD do not include such a requirement. Such an audit activity has been described previously, very briefly in EN ISO 14155-1:2003, and in somewhat more detail in EN ISO 14155:2011. EN ISO 14155:2020, however, includes a new informative Annex on clinical investigation audits, which provides general guidance on the areas that should be checked during the audit. This presentation will discuss the guidance on GCP audits in EN ISO 14155:2020 and provide practical advice on the organization, conduct and documentation of the audit process.

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