The European Commission’s Medical Device Coordination Group (MDCG) offers guidance on clinical investigations under MDR, Regulation (EU) 2017/745.
In the guidance document, MDCG addressed 28 commonly asked questions about the clinical investigations along with 2 annexes on the regulatory pathway of clinical investigation under MDR and non-exhaustive list of medications that may be interpreted as substantial.
Clinical evidence is not a new requirement, but the new EU MDR is full of new clinical investigation requirements. The bar has been raised not just on the requirements surrounding clinical evidence, but on the level of examination now expected. Clinical documentation is going to need to be re-evaluated and revised to meet the new legislative of MDR.
Source: MDCG 2021-6 (https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-6_en.pdf)
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