Clear Clinical Documentation for Approval

Clinical writing for medical devices to build strong clinical evidence, meet regulations, and secure market approval.

What Do We Offer?

Clinical compliance documentation is often the most uncertain part of a medical device submission. Medical device clinical evaluation is usually the final validation step before completing the technical documentation to facilitate review by a (global) regulator.

For many medical devices, there are no strict requirements for the minimum level of clinical evidence, and the needed evidence can vary by regulatory jurisdiction. It is ultimately the manufacturer’s responsibility to evaluate and justify the appropriate level of clinical evidence required for clearance or approval.

In the United States, manufacturers can liaise with the FDA through the pre-submission process to collect informal feedback on their clinical evidence to be gathered. In the European Union, there are limited opportunities for direct interactions with regulators (e.g., structured dialogues), meaning manufacturers often need to define their clinical validation strategy without consulting a Notified Body.

A common approach is to assess the current clinical standard of care and regulatory State-of-the-Art (SOTA) based on relevant standards, regulations, and guidelines. This helps manufacturers understand the clinical and regulatory performance requirements for their medical devices. The process involves conducting in-depth, systematic literature research and determining the level of clinical data needed.

If necessary, manufacturers may conduct a clinical investigation per ISO 14155 to collect evidence, either prospectively or retrospectively. Clinical writing for medical devices plays a crucial role in compiling and presenting this data, and setting up the device labelling. Based on all gathered clinical evidence—from literature reviews to study data—and risk assessment conclusions, manufacturers must demonstrate that the benefits of the medical device outweigh the potential risks.

Services

• Clinical evidence-level assessment
• Predicate data evaluation for 510(k) submissions (US)
• Preparation of a clinical development plan
• Execution of a systematic literature review
• Post-market surveillance analysis (e.g., FDA MAUDE, Australian DAEN)
• Clinical Evaluation Plan (CEP) & Report (CER)
• Clinical evaluation training and auditing
• Post-market clinical support, (PMS & PMCF plans)
• Clinical study protocol review (prospective & retrospective)

Relevant Resources - EU

• MDCG 2024-15: Clinical Investigation Reports Publication Guidance
• MDCG 2024-10: Clinical evaluation of orphan medical devices
• MDCG 2024-5: Guidance on the Investigator’s Brochure content

Relevant Resources - EU

• MDCG 2024-15: Clinical Investigation Reports Publication Guidance
• MDCG 2024-10: Clinical evaluation of orphan medical devices
• MDCG 2024-5: Guidance on the Investigator’s Brochure content
• MDCG 2024-5: Appendix A of the MDCG 2024-5
• MDCG 2024-3: Clinical Investigation Plan Guidance
• MDCG 2024-3 Appendix A: Clinical Investigation Plan Synopsis Template
• MDCG 2023-7: Guidance on Clinical Investigation Exemptions & Equivalence Data
• 2023/C 163/06: Guidance on Summary of Clinical Investigation Report
• MDCG 2021-28: Substantial Modification of Clinical Investigation under MDR
• MDCG 2021-20: Generating CIV-ID for MDR Clinical Investigations
• MDCG 2021-8: Clinical investigation application/notification documents
• MDCG 2021-6 - rev.1: Q&A on Clinical Investigation – Regulation (EU) 2017/745
• MDCG 2020-13 - Clinical Evaluation Assessment Report Template
• MDCG 2020-10/1 rev.1: Guidance on Safety Reporting in Clinical Investigations
• MDCG 2020-10/2 rev.1: Appendix: Clinical investigation summary safety report form
• MDCG 2020-8: Guidance on PMCF evaluation report template
• MDCG 2020-7:Guidance on PMCF Plan Template
• MDCG 2020-6: Relationship Between MDCG 2020-6 and MEDDEV 2.7/1 Rev. 4 on Clinical Evaluation
• MDCG 2020-5: Guidance on clinical evaluation – Equivalence
• MDCG 2019-9 - rev.1: Summary of safety and clinical performance

Relevant Resources - US

• FDA guidance on clinical performance assessment for 510(k) submissions
• FDA guidance on clinical evaluation of Software as a Medical Device (SaMD)
• FDA decisions on Investigational Device Exemption (IDE) clinical investigations

Relevant Resources - US

• FDA guidance on clinical performance assessment for 510(k) submissions
• FDA guidance on clinical evaluation of Software as a Medical Device (SaMD)
• FDA decisions on Investigational Device Exemption (IDE) clinical investigations
• FDA regulations on good clinical practice and clinical trials

Relevant Resources - Others

• Declaration of Helsinki
• IMDRF: Technical document Clinical Investigation
• IMDRF: Post-Market Clinical Follow-Up Studies

Relevant Resources - Others

• Declaration of Helsinki
• IMDRF: Technical document Clinical Investigation
• IMDRF: Post-Market Clinical Follow-Up Studies
• IMDRF: Clinical Evidence - Key Definitions and Concepts

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