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Device study planning should begin with intended purpose, CE status and study procedures rather than an assumption that all research uses CTIS.
MDR clinical investigations — Define the regulatory scope
MDR Articles 62, 74 and 82 address different clinical investigation contexts. MDCG 2021-6 helps interpret the route; national requirements remain relevant.
MDR clinical investigations — Build the working record
Prepare a route memo covering conformity-assessment purpose, CE marking, use within intended purpose and additional invasive or burdensome procedures. Identify submission, ethics and country requirements before finalising site contracts.
MDR clinical investigations — Check before release
- Verify the device version and intended use.
- Describe procedures beyond normal use.
- Confirm each country submission channel.
MDR clinical investigations — Record the decision and handover
Approve the route with regulatory and clinical owners. Keep the rationale with the investigation plan, and reassess it when the device or procedures change; medicinal product trial permission does not replace device requirements.
Frequently asked questions
- Does CE marking remove every study requirement?
- No. Intended purpose, extra procedures and the applicable route still matter.
- Is CTIS the general device study portal?
- No. CTIS serves medicinal product trials; use the applicable device pathway.