EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations

[lyannastark]

Hello,

I am trying to understand MDR requirements for clinical investigations. But it is not clear to me whether a CRO located outside the Union can conduct clinical investigations in the Union (or outside the Union to comply with NB demands).

In Article 62, paragraph (2), there is a statement as follows:

2.Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor. Member States may choose not to apply the first subparagraph to clinical investigations to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical investigation who shall be the addressee for all communications with the sponsor provided for in this Regulation.

It says Sponsor, but does it also apply for CROs?

Thank you in advance

 

[Ronen E]

Re: EU MDR CRO (Contract Research Organization) requirements for Clinical Investigati

Definition 49 in the MDR's Article 2 reads:

‘sponsor' means 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;

If the CRO meets this definition, it is subject to the requirements called out for Sponsors. If it doesn't, there should be another entity taking on the Sponsor's role, in which case those requirements won't apply to the CRO.