Clinical investigations and the MDR: sponsors and legal representatives

The MDR has introduced the term ‘sponsor’

The MDR introduces new requirements, which need to be carefully reviewed and addressed in applicable procedures for the conduct of clinical investigations under the MDR. The new MDR requirements presented here are among those that will most likely require changes in the conduct of a clinical investigation even if BS EN ISO 14155:2020 and European clinical investigation-related guidance documents have been followed.

Introduction of ‘sponsor’

The MDR has introduced the term ‘sponsor’, defining it in MDR Article 2(49), as:

‘any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation.’

This is important, because under the Directives, only the manufacturer or authorized representative is identified as the responsible party for the conduct of a clinical investigation. This has resulted in some uncertainty regarding the regulatory responsibility of an independent clinical investigator who initiates a medical device clinical investigation.

Under the MDR, the definition of ‘sponsor’ means that clinical investigators initiating clinical studies will be responsible for meeting MDR clinical study-related requirements. However, this does not prevent agreements on study conduct between investigators and manufacturers. It will be useful, however, for manufacturers intending to support the study or use the study results for regulatory purposes, to ensure that the investigator acting as a study sponsor is aware of sponsor-related requirements under the MDR.

Legal representative

Under MDR Article 62, General requirements regarding clinical investigations conducted to demonstrate conformity of devices, a legal representative must be designated when the sponsor of a clinical investigation to be conducted in the European Union (EU) is not in the EU. The legal representative will be responsible for ensuring compliance with the sponsor’s obligations. The MDR allows, however, a Member State the option of not applying this requirement if the study is conducted only in the territory of the Member State. Unless exempted, this is an important new requirement that a non-EU sponsor conducting a clinical investigation in the EU will need to address.

This is an excerpt from the BSI medical devices white paper: Medical device clinical investigations – What’s new under the MDR? To browse our collection of medical device white papers, please visit the Insight page on the Compliance Navigator website.