clinical investigation plan

Defined in Article 2, Medical Device Regulation (MDR)

Definitions over time (2)

1. 24/04/2020 – today applies on 12/11/2026 Article 2, Medical Device Regulation (MDR) Scope: Whole act

   For the purposes of this Regulation, the following definitions apply:

   ‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;

2. 05/05/2017 – 25/05/2017 Article 2, Medical Device Regulation (MDR) Scope: Whole act

   For the purposes of this Regulation, the following definitions apply:

   ‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;

Used in (17 places in 8 provisions on 12/11/2026)

Medical Device Regulation (MDR) (17 in 8)

Article 2 · Article 62 · Article 68 · Article 72 · Article 77² · Article 80² · Annex VII · Annex XV⁸