Sponsor’s Authorized Consultant: Function and Accountability

To help the events concerned in decoding and following the relevant regulatory necessities, the authority additionally describes intimately the essential elements related to the regulatory standing of a authorized consultant of a examine sponsor.

By the relevant regulatory necessities, a pure or authorized individual should be established as its authorized consultant if the sponsor will not be based mostly within the Union. This consultant ensures compliance with the MDR and is the first contact for all regulatory communications.

Nevertheless, it’s important to say that the authorized consultant can’t delegate the duty of making certain MDR compliance to the sponsor or a Contract Analysis Group (CRO).
The sponsor is really useful to supply an influence of lawyer to the authorized consultant and a contract obligating the sponsor to produce the mandatory info.

Whereas the authorized consultant can delegate particular duties, the last word duty for MDR compliance stays with them. This contains making certain that contracts with different entities cowl the sponsor’s obligations below the MDR.

The authorized consultant’s position extends to auditing the sponsor and subcontractors, making certain entry to technical documentation, and verifying compliance with the MDR. They need to additionally maintain information of those verification actions, though this doesn’t entail taking part in information analysis or assessment.

The authorized consultant will need to have unrestricted entry to the whole investigation grasp file, together with contracts, monetary preparations, {qualifications} of investigational websites and entities, and security reviews. This ensures readiness to supply paperwork to authorities upon request.

The MDCG additionally emphasises that following the MDR, documentation should be accessible to competent authorities, even when the sponsor goes bankrupt or ceases actions. This confirms the significance of safe storage throughout the EEA and Türkiye.

The current MDCG steering describes how scientific investigations involving medical gadgets needs to be deliberate and carried out.