EU MDR / IVDR-ready clinical evaluation.
Clinical Evaluation Reports authored with the same source-traceability engine used for CSRs — traceable claims, tamper-evident audit, MDR-ready evidence.
Every statement in the draft links to its source, such as AE listing 16.2.7, so the reviewer checks it in place.
A Clinical Evaluation Report demonstrates a medical device achieves its intended clinical performance and that benefits outweigh risks, under EU MDR Annex XIV and MEDDEV 2.7/1 rev 4. It is a continuous obligation updated as evidence appears. Notified bodies challenge equivalence claims that are asserted rather than demonstrated, and literature appraisal that is visibly out of date.
Outcomes you can expect
- EU MDR / IVDR CER
- Traceable clinical claims
- Post-market surveillance hooks
Clinical Evaluation Reports (CER) is delivered by our clinical services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Medical Writing Services, Clinical Study Report (CSR) Authoring, Protocol & Protocol Amendment Writing, Clinical Documentation Services.
The EU MDR Clinical Evaluation Report: Annex XIV Requirements
EU MDR Annex XIV Part A defines the clinical evaluation methodology and the Clinical Evaluation Report that documents it. The CER must cover: the device description and intended purpose; the clinical evaluation plan; the clinical data identified through systematic literature review; the clinical data from clinical investigations conducted for the device; the assessment of clinical data including equivalence claims; the conclusions on the clinical safety, performance, and benefit-risk profile; and the summary of safety and clinical performance (SSCP) for implantable and Class III devices.
The MDR standard for equivalence claims is significantly more demanding than the MDD predecessor. To claim equivalence to another device, the manufacturer must demonstrate technical equivalence (same design principles, materials, specifications, deployment forces, interfaces, operating principles), biological equivalence (same materials in contact with the body), and clinical equivalence (same clinical condition, same target population, same intended purpose, same part of the body). For the technical and biological equivalence claims, the manufacturer must have documented access to the technical documentation of the predicate device — which in practice means contractual access to the reference device manufacturer's technical file. This requirement is practically unachievable for third-party devices, forcing most manufacturers to build clinical evidence independently.
- 1Adverse event listing · row 14
- 2Lab dataset · ALT value, day 15
- 3Protocol · section 7.2
Systematic Literature Review Methodology for CERs
The systematic literature review (SLR) is the data identification foundation of the CER. It must be conducted according to a pre-specified search strategy that is documented in the clinical evaluation plan. The search must cover all relevant published clinical data for both the subject device and the equivalent or comparable devices, across all applicable databases (PubMed, Embase, COCHRANE, and device-specific registries). The search strategy, inclusion and exclusion criteria, and screening process must be documented with enough precision that a peer reviewer could reproduce the search and arrive at the same included study set.
TraceDraft's SLR module structures the systematic review process: the search strategy is documented in a pre-specified protocol, search results are imported and screened against inclusion/exclusion criteria with each screening decision recorded and attributable, included studies are data-extracted into a structured summary, and the evidence appraisal is conducted against a defined quality scoring framework. The CER's clinical data section is generated directly from the SLR structured data, with source citations embedded and the methodological documentation linked. This produces a CER whose evidence base is reproducible, transparent, and aligned with the MEDDEV 2.7/1 revision 4 methodology that notified bodies apply in their review.
Post-Market Clinical Follow-Up Integration
EU MDR Article 83 and Annex XIV Part B require that manufacturers conduct Post-Market Clinical Follow-Up (PMCF) as part of their post-market surveillance system. PMCF is the ongoing collection of clinical data after market authorisation that allows the manufacturer to proactively update the clinical evaluation and monitor the real-world performance and safety of the device. The PMCF plan must be documented in the CER, and PMCF evaluation reports must feed back into the CER update cycle.
TraceDraft maintains the CER as a living document through the device's regulatory life — not as a static point-in-time assessment. As new clinical evidence becomes available through PMCF activities, new literature publications, or new clinical investigations, the CER is updated to incorporate the new data. The update history is maintained with version control and audit trail, providing a complete record of how the clinical evidence base has evolved since initial MDR authorisation. For Class III and implantable device manufacturers facing periodic CER review by notified bodies, this living document approach produces a CER that is always current rather than requiring reconstruction from scratch at each update cycle.
See it on your own system.
Bring a protocol, a TLF set or an AE listing. We show you the source-traced draft it produces.
- We reply within one business day
- We run your inputs live on the call
- You get a clear plan and scope