December 12, 2023
Manufacturers marketing medical devices in the EU will want to take note of updated frequently asked questions (FAQs) regarding the clinical investigations section of the Medical Device Coordination Group (MDCG) document MDCG 2021-6 Rev. 1 (MDR 2017/745). The document has undergone significant changes.
Among the highlights:
- 19 questions have been added
- One question was modified
- Two questions have been updated
- The revised MDCG guidance further clarifies clinical investigation requirements
Revised MDCG guidance clarifies many more clinical investigation requirements
The revised MDCG guidance now clarifies:
- Whether other legislation than the MDR might need to be taken into account when conducting a clinical investigation (CI).
- Which investigations that include one of your devices are deemed to be a CI, according to the MDR.
- Which Chapter VI articles, Clinical Evaluation and Clinical Investigation (articles 61 – 82 MDR) apply to which investigation types.
- How studies that include a combination of medical device(s) and medicinal products should be handled (do MDR requirements apply? Is there a common EU procedure?). The MDCG FAQ also covers CIs conducted to collect data for a medicinal product and a medical device intended to administer that medicinal product (non-integrated).
- Whether usability tests and retrospective CIs fall within the MDR CI definition.
Additionally, the FAQ document clarifies when a CI will need to be terminated, as well as record retention requirements, availability of CI summary templates and applications made via EUDAMED. Lastly, the revised MDCG gives guidance on the responsibilities of the legal representative that should be appointed by sponsors located outside the EU.
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