Clinical data is information about a medical device’s safety or performance that comes from its use in or on human subjects. Under EU MDR 2017/745, it is drawn from clinical investigations, equivalent-device studies, peer-reviewed literature, and post-market surveillance, and forms the basis of a device’s clinical evidence.
What is clinical data?
Clinical data is central to proving a device is safe and performs as intended. EU MDR 2017/745 Article 2(48) defines it as information concerning safety or performance generated from the use of a device. It is distinct from clinical evidence, the assessed and analyzed body of clinical data plus the conclusions drawn from it.
Clinical data feeds the clinical evaluation, the systematic process described in Article 61 and Annex XIV of the MDR. That evaluation produces the Clinical Evaluation Report (CER), which a notified body reviews during conformity assessment. So clinical data is the raw input, clinical evidence is the analyzed result, and the CER carries it.
Why clinical data matters in medical device development
Clinical data is a gating requirement for market access. Under MDR Article 61, manufacturers must base conformity with the general safety and performance requirements on clinical data that provides sufficient clinical evidence. Without it, a CE certificate will not be issued.
The stakes scale with risk class. Class III and implantable devices almost always need data from a clinical investigation of the device itself. For lower-risk devices, literature and post-market data may be enough, though notified bodies interpret “sufficient” inconsistently, a frequent cause of review questions and certificate delays.
Gaps cost time and money. Weak or missing clinical data is a common reason CERs are rejected, and the fix often means running a study late, after design freeze, when changes are most expensive. Audit exposure is real too: notified bodies expect the data trail to be traceable, current, and consistent with the device’s claims.
How clinical data is generated and sourced
EU MDR Article 2(48) names four sources of clinical data. A device’s clinical evidence usually draws on more than one.
- Clinical investigation of the device in question, conducted to ISO 14155, the good clinical practice (GCP) standard for device studies.
- Clinical investigations or other studies of a device for which equivalence to the subject device can be demonstrated.
- Reports in peer-reviewed scientific literature on clinical experience with the device or an equivalent device.
- Clinically relevant information from post-market surveillance, in particular post-market clinical follow-up (PMCF).
A clinical investigation, where needed, is governed by Annex XV of the MDR and ISO 14155. The current edition is ISO 14155:2026, published in March 2026, which replaced the 2020 version with no transition period. One caveat for regulatory teams: EN ISO 14155:2020 remained the harmonized version for MDR conformity as the new edition rolled out, so confirm the current harmonized version in the EU Official Journal before citing it in a technical file.
In the United States, the FDA expects clinical data for PMA submissions, De Novo requests, and some 510(k)s, with studies run under the Investigational Device Exemption rule, 21 CFR Part 812. For in vitro diagnostics, EU IVDR 2017/746 frames the equivalent concept as performance evaluation: scientific validity, analytical performance, and clinical performance.
Common challenges and best practices
The recurring mistake is treating clinical data as a late submission task rather than a planned evidence strategy. Good teams define clinical evidence requirements during design planning, map them to the intended purpose and claims, and decide early whether equivalence, literature, or a new investigation will carry the load.
Equivalence is where many CERs fail. The MDR sets a high bar across technical, biological, and clinical characteristics, and access to the equivalent device’s technical documentation is often required. If it cannot be defended, the fallback is usually a clinical investigation, so test the argument with the notified body early.
Data quality is the other common gap. Clinical data must be traceable to source, collected under GCP, and managed so it can withstand an audit. Strong programs keep PMCF data flowing back into a living clinical evaluation plan and version-control every literature search so the appraisal can be reproduced.
How SJML helps with clinical data
Syrma Johari MedTech (SJML) supports clinical data work through its Compliance-as-a-Service practice. Teams handle clinical evaluation planning and reporting, literature review and appraisal, clinical data management, and Summary of Safety and Clinical Performance (SSCP) preparation. SJML also plans and runs post-market surveillance and post-market clinical follow-up, feeding real-world data into the evaluation. Because this sits alongside SJML’s design, engineering, and regulatory teams, evidence strategy is set early rather than retrofitted. Support spans EU MDR, IVDR, and FDA pathways.
Frequently asked questions
Clinical data is the raw information about a device’s safety or performance generated from its use, such as investigation results, literature, or post-market findings. Clinical evidence is what you get after that data is appraised and analyzed: the assessed body of data plus the conclusions drawn from it. Clinical data is the input, and clinical evidence is the reasoned output used to demonstrate conformity.
No. A clinical investigation is one of four MDR sources of clinical data. Lower-risk devices can often build sufficient clinical evidence from literature, equivalent-device data, and post-market clinical follow-up. Class III and implantable devices usually do require a clinical investigation of the device itself. The right route depends on risk class, novelty, available equivalence, and the strength of existing data.
ISO 14155 is the international standard for good clinical practice in clinical investigations of medical devices. The current edition is ISO 14155:2026, published in March 2026, which replaced the 2020 version with no transition period. For EU MDR conformity, confirm the harmonized version in the Official Journal, since EN ISO 14155:2020 was still the harmonized reference as the 2026 edition rolled out.
Post-market surveillance and post-market clinical follow-up in particular are explicit sources of clinical data under MDR Article 2(48). PMCF generates real-world safety and performance information after launch, which feeds back into the clinical evaluation. This keeps the clinical evidence current across the device lifecycle and supports periodic updates to the CER and, where required, the SSCP.
Related terms
- Clinical Evaluation
- Clinical Investigation
- Post-Market Clinical Follow-up (PMCF)
- Clinical Evaluation Report (CER)
- ISO 14155
