Why transparency has become a central issue
Clinical investigation transparency in medical devices (MDs) has become a cornerstone of trust and regulatory compliance.
Once considered a matter of ethics, it is now a legal requirement under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
These regulations require sponsors and manufacturers to publish all clinical investigation results — whether positive or negative — to ensure patient safety, scientific integrity, and transparency in clinical research.
This evolution marks a profound shift: clinical data are no longer just a regulatory requirement but a strategic asset that strengthens credibility and competitiveness for manufacturers.
A stricter regulatory framework for clinical investigation transparency
Articles 77 (MDR) and 73 (IVDR) set out clear obligations:
- The Clinical Investigation Report (CIR) and a layperson summary must be made public.
- This summary must be submitted within one year after the end of the investigation, or earlier if the device is registered in advance.
- Data will be centralized in the EUDAMED database, whose dedicated clinical module is expected to go live by late 2026.
Until then, sponsors must submit results through platforms such as CircABC or national systems (e.g., SI-RIPH or ECLAIRE in France).
Failure to publish results — even negative ones — within the required timeframe can lead to sanctions and reputational damage for the manufacturer.
References: Règlement (UE) 2017/745 articles 77 & 29 ; ISO 14155 ; European Guidance 2023/C 163/06.
Transparency: a lever for trust and safety
Making clinical investigation results public helps to:
- Strengthen trust among healthcare professionals and patients,
- Support informed public health decisions,
- Promote responsible innovation through shared scientific knowledge.
When safety and performance data are accessible, authorities, clinicians, and patients can better assess a device’s real benefit-risk profile.
For manufacturers, transparency signals a commitment to credibility and corporate responsibility — two pillars of long-term success.
Read also: European Commission – EUDAMED and transparency
Best practices for successful transparency
1. Register studies in public databases
Before launching a clinical study, investigations must be registered in a public database such as ClinicalTrials.gov, EUDAMED (upcoming), or ECLAIRE in France (Open Clinical Trials Platform).
This ensures traceability and public access to protocols and results.
2. Publish comprehensive and readable results
All results — including adverse events and safety outcomes — should be disclosed in a standardized, understandable format.
Frameworks such as ISO 14155 Annex D or the CONSORT guidelines enhance readability and consistency.
3. Include negative or partial outcomes
Publishing only positive results distorts scientific reality.
Negative or inconclusive results must also be made public — it’s both an ethical and scientific requirement.
Failure to disclose them risks publication bias and damages scientific integrity.
4. Open and multi-channel publication
Sponsors should prioritize public databases but can also disseminate findings via scientific journals, conference abstracts, or posters.
In France, the ECLAIRE platform already tracks more than 19,200 studies, including 918 clinical investigations on medical devices and 94 performance studies on IVDs as of September 2025.
More information: ECLAIRE – Open API for clinical research in France.
Transparency and CSR: a strategic advantage for manufacturers
Ensuring transparency in clinical results is no longer only about compliance — it is a corporate social responsibility (CSR) marker and a competitive differentiator.
Manufacturers who proactively disclose their results:
- Enhance their brand reputation and scientific credibility,
- Reduce regulatory and legal risks,
- Accelerate future CE marking approvals by demonstrating data reliability,
- Contribute to a more open and collaborative innovation ecosystem.
“Sharing data builds trust in innovation — and strengthens patient safety.”
In summary
Clinical investigation transparency is now a regulatory, scientific, and strategic pillar of the medical device industry.
It requires rigorous documentation and ethical accountability, but rewards manufacturers with greater recognition, regulatory trust, and faster access to the European market.
At BluePharm, we support manufacturers by providing:
- Medical writing and harmonization of Clinical Investigation Reports (CIRs),
- Submission assistance to competent authorities (EUDAMED, ANSM, CircABC),
- Compliance with MDR and ISO 14155 publication requirements.
Because well-shared data leads to better-understood innovation — and safer patients.
Based on the article (attached) published in DeviceMed Magazine, November-December 2025 issue. Clinical investigations and transparency by Carla Lippens and Maurice Bagot d’Arc from the DM group of the AFCROs.
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