Six documents covering the full clinical investigation lifecycle — from feasibility protocol through pivotal study planning, SAE reporting, and risk-benefit documentation for EU MDR submissions.
For clinical affairs managers and RA leads at medical device companies pursuing CE marking or FDA approval.
Notified bodies and Ethics Committees reject clinical investigation submissions for predictable reasons: CIPs missing Annex XV elements, SAE reporting procedures without defined timelines, Investigators' Brochures missing risk-benefit summaries, and CIAs that don't address ISO 14155 contractual requirements.
Each rejection adds months and significant cost. This toolkit gives you documentation built to the standard that passes first-round review.
From feasibility protocol through SAE reporting and risk-benefit documentation.
Full-scope CIP template aligned with ISO 14155:2020 and EU MDR Annex XV. Covers study objectives, investigational device description, study design, eligibility criteria, endpoints, statistical methods, monitoring plan, and regulatory submission structure for both feasibility and pivotal investigations.
Early-phase clinical protocol for first-in-human and feasibility studies. Includes safety monitoring framework, preliminary endpoint definition, sample size rationale for feasibility objectives, and report structure for transition to pivotal investigation planning.
IB template covering device description, preclinical and clinical data summary, risk-benefit assessment, and guidance for investigators. Structured to meet ISO 14155 requirements for sponsor obligations and investigator information disclosure at study initiation.
Comprehensive CIA covering sponsor and investigator obligations, regulatory compliance requirements, data ownership, confidentiality, publication rights, and indemnification provisions. Aligned with ISO 14155 contractual requirements for medical device clinical investigations.
Step-by-step SAE identification, grading, and reporting procedure covering 24-hour notification timelines, causality assessment, safety reporting to competent authorities, EC/IRB requirements, and annual safety reporting under ISO 14155 and EU MDR vigilance obligations.
Structured risk-benefit analysis for clinical investigation design. Covers device risks, investigational procedure risks, patient population vulnerability, risk mitigation measures, benefit assessment, and benefit-risk conclusion documentation required for ethics committee and regulatory submissions.
Every template reflects current ISO 14155:2020 requirements and EU MDR Annex XV clinical investigation obligations. One set of documents works for Ethics Committee submissions, notified body review, and competent authority requirements.
The toolkit covers early-phase feasibility protocol through pivotal investigation planning. The transition framework between phases is built in — reducing gaps that cause competent authority queries.
The SAE SOP and Clinical Investigation Risk Assessment are the two most frequently deficient elements in clinical investigation submissions. Both are pre-structured with causality assessment criteria and benefit-risk conclusion documentation.
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“Our notified body reviewed the CIP structure and said it was the cleanest they had seen from a first-time sponsor. We passed our Ethics Committee review on the first submission. The ISO 14155 template covered everything — objectives, endpoints, statistical justification. Zero major deficiencies.”
“The SAE Reporting SOP was exactly what our CRO needed. We had three sites across two countries with no consistent SAE workflow. This template became the foundation of our safety reporting system. The 24-hour notification timelines and causality assessment criteria were pre-built — we just customized for our device.”
“We needed a Feasibility Study Protocol fast to get into our first FIH study. The template cut our protocol development time in half. The transition framework from feasibility to pivotal study planning is something we would have had to build from scratch — it was already in there.”
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