EU MDR and IVDR clinical evaluation, written by a physician

Clinical Evaluation Report writing, IVDR performance evaluation, PMCF, PSUR and notified body deficiency response support, produced as a subcontracted evidence workstream for regulatory affairs teams and consultancies.

Clinoble provides an EU MDR clinical evaluation report writing service and an IVDR Annex XIII performance evaluation service for medical device and in vitro diagnostic manufacturers, and for the regulatory consultancies that support them. The work is authored by Dr. Jaideep Rao M., MBBS, MD Community Medicine, founder of Clinoble Innovations Private Limited, working as a physician author on the clinical evidence, evaluation and appraisal steps of each deliverable. Where a manufacturer or consultancy needs an EU MDR CER expert to write, refresh or defend a Clinical Evaluation Report, or an IVDR performance evaluation report built around scientific validity, analytical performance and clinical performance, that is the scope this page covers. The two governing texts throughout are Regulation (EU) 2017/745 for medical devices and Regulation (EU) 2017/746 for in vitro diagnostics.

Clinical Evaluation Reports and MEDDEV 2.7/1 Rev 4 under the MDR

Clinical Evaluation Report preparation follows the structure required for MDR Article 61 and Annex XIV Part A, using MEDDEV 2.7/1 Rev 4 as the working methodology guide for the clinical evaluation process, the evaluation plan, the appraisal of clinical data and the benefit-risk conclusion. This covers new CER authorship as well as updates to an existing report where the underlying literature, complaint data or state-of-the-art chapter has moved on since the last version. As a clinical evaluation report preparation service, the output is written to sit directly inside a manufacturer's technical documentation, referencing the intended purpose, indications and claims exactly as the manufacturer has defined them.

Each report is built as a traceable chain rather than a narrative: the intended purpose and claims are decomposed into the specific clinical questions the evidence has to answer, the clinical evaluation plan states in advance how data will be identified and appraised, and the appraisal tables show what weight each source carried and why. Clinical data generated by the manufacturer, data on equivalent devices where equivalence can be argued, and published literature are kept as distinct evidence streams so that a reader can see which conclusion rests on which stream. The benefit-risk discussion then closes against the risk management file and the information supplied with the device, and any residual clinical uncertainty is written into the report as an open question with a proposed route to close it, usually through post-market clinical follow-up.

IVDR Annex XIII performance evaluation, across all three pillars

For in vitro diagnostics, performance evaluation work is structured around the three pillars set out in IVDR Annex XIII: scientific validity of the analyte-disease association, analytical performance of the assay itself, and clinical performance of the device in its intended use population. Each pillar is evaluated and documented separately, with the appraisal and synthesis work cross-referenced back into the Performance Evaluation Report and, where applicable, the Performance Evaluation Plan.

Keeping the pillars separate matters in practice, because the evidence types behind them differ. Scientific validity is largely a literature and reference-standard argument about the association itself; analytical performance is a laboratory characterisation argument about how the assay behaves against known material; clinical performance is an argument about what the result means for a defined population and intended use. Writing them as one undifferentiated section is a common source of assessor queries, so the deliverable keeps the boundaries explicit, states which claim each pillar supports, and identifies where a gap in one pillar limits what the other two can conclude.

Notified body deficiency response and state-of-the-art chapters

When a notified body raises a clinical evaluation deficiency, the response work covers rebuilding the specific evidence chain the deficiency letter is querying: re-running the literature appraisal against the objection, tightening the benefit-risk argument, or rewriting the affected section of the CER or PER so the response reads as a coherent update rather than a patch. Responses are written to be read alongside the original document, with a change log that points the assessor to exactly where each point was addressed.

State-of-the-art chapters are written and refreshed as a standalone deliverable as well, covering the therapeutic or diagnostic area, alternative treatment or testing options, applicable standards and guidance, and the clinical background a CER or PER needs to justify its comparator and equivalence reasoning. Because the state of the art moves independently of the device, this chapter is normally the first part of a report to age, and it is treated as a maintainable component rather than something rewritten from scratch each cycle.

PMCF plans and reports, and PSUR periodicity under Article 86

Post-Market Clinical Follow-up work spans both the PMCF plan required under MDR Annex XIV Part B and the PMCF evaluation report that closes the loop on it, feeding conclusions back into the CER's benefit-risk section. A usable PMCF plan states which residual question from the clinical evaluation it exists to answer, what method will answer it, and what the report will look like when it does; a PMCF evaluation report that cannot be traced back to a question raised in the CER is difficult for an assessor to accept.

Periodic Safety Update Report drafting follows the periodicity set out in MDR Article 86: class IIb and class III devices update the PSUR annually, and class IIa devices at least every two years. Class I devices use a periodic safety update report only where required, and otherwise a post-market surveillance report under Article 85. Article 88 trend reporting inputs are incorporated where the manufacturer supplies them. This is written as a documentation service, not a vigilance system: the manufacturer remains responsible for its own trend-reporting obligations, its post-market surveillance procedures and any regulatory reporting arising from them.

Equivalence and gap analysis referencing MDCG 2020-5

Where a manufacturer wants to rely on equivalent device data, the equivalence assessment is built against the clinical, technical and biological characteristics framework in MDCG 2020-5, with a gap analysis that states plainly where the equivalence argument is strong, where it is thin, and what additional clinical data would close the gap. The same discipline applies to legacy-device evidence questions that reference MDCG 2020-6 on sufficient clinical evidence, and to reports that will ultimately be read against the MDCG 2020-13 clinical evaluation assessment report template used by notified bodies. Writing with that template in view means the report answers the questions an assessor is required to work through, in a sequence they can follow.

Protocol-driven literature search and appraisal

Literature work for a CER or PER is run against a pre-specified search protocol: defined databases, search strings, inclusion and exclusion criteria, and an appraisal methodology applied consistently across every retrieved article before any of it is weighted into the evaluation. Records are tracked from retrieval through screening to inclusion, with reasons recorded for exclusions at full-text stage. The protocol itself is delivered alongside the search results and appraisal tables, so a reviewer or notified body assessor can trace every conclusion in the report back to a specific, reproducible search step, and so the same search can be re-run at the next update without reconstructing the method from memory.

Computational preclinical evidence design

For manufacturers still building their nonclinical and translational evidence base, Clinoble also designs the earlier-stage evidence workstream: target rationale framing, disease model selection, study design for the nonclinical programme, synthesis of the resulting evidence, biomarker and dose translation reasoning from model to human, and the nonclinical regulatory writing that feeds into a technical file or an IVDR analytical and scientific validity dossier. This is offered as a design and writing service; it does not include running the laboratory or animal studies themselves.

Who carries the revision risk

Revision cycles on the evidence work Clinoble produces are covered inside the same fee, limited strictly to notified-body queries raised against that specific deliverable's evidence content — for example, a literature appraisal, an equivalence argument, or a state-of-the-art section that a notified body assessor has questioned. This does not cover changes to the device itself, changes to claims or intended purpose, or the manufacturer's own regulatory submission and its outcome. A deficiency letter that asks for new evidence work on the same deliverable is in scope; a deficiency letter that asks the manufacturer to change what the device does, or how it is labelled, is a manufacturer decision outside this service.

What this service does not do

Clinoble is an evidence-writing and evidence-design subcontractor. It does not act as a notified body, an authorised representative or a Person Responsible for Regulatory Compliance, and it does not issue any form of clearance, marking or attestation. It does not hold or operate the manufacturer's quality management system, and it does not submit documentation on the manufacturer's behalf. Deliverables are drafted against the documentation and data the manufacturer supplies, and the manufacturer reviews, approves and owns the final version that enters its technical documentation. No outcome before a notified body or any authority is promised, because that outcome depends on the device, the data behind it and the manufacturer's wider file.

Who this is for

This service is built for EU, UK and US medical device and IVD regulatory affairs leads who need an EU MDR regulatory consultant to produce a specific clinical evidence deliverable, and for small and mid-size notified-body-facing manufacturers who need clinical evaluation or performance evaluation writing capacity without adding headcount. It also serves regulatory consultancies that want a notified body CER writing consultant to subcontract overflow CER, PER, PMCF, PSUR or deficiency-response work to, under their own client relationship and their own quality system. Work can be delivered in the consultancy's own templates where they have them.

How an engagement is scoped

Engagements are scoped per deliverable — a CER, a PER, a PMCF plan or report, a PSUR, a deficiency response, an equivalence and gap analysis, or a preclinical evidence design package — rather than as a fixed retainer. Scoping starts from the documents that already exist: the intended purpose and claims, the risk management file, any prior clinical evaluation or performance evaluation, the current literature set, post-market data, and, where relevant, the deficiency letter itself. From those, the scope statement records what is being written, what the manufacturer supplies, what is explicitly excluded, and what the review and handover steps are. These clinical evaluation and performance evaluation services are available now, and each engagement is agreed against the specific documentation the manufacturer or consultancy provides.