Medical Device and IVD Regulatory Writing for Manufacturers
Pubrica prepares the clinical, performance and post-market documentation that medical device and IVD manufacturers need under EU MDR and IVDR. Under MDR and IVDR, evaluation is continuous: a plan precedes each report, post-market data feeds back into both, and the state of the art must be re-established at each update. Our device and IVD regulatory writers prepare all twelve documents in the order the regulations expect, from clinical and performance evaluation plans and reports to PMCF, PMS, device PSUR, SSCP, risk management and technical file documentation.
- Plan before report, because a clinical evaluation report without an approved CEP is a common and predictable notified body deficiency
- Documented state of the art, supported by a reproducible search, as the benchmark against which every claim is judged
- Post-market obligations set by class: PSUR annually for IIb and III, at least every two years for IIa, a PMS report for class I under Article 85
- IVDR documents prepared separately, covering performance evaluation, scientific validity and analytical and clinical performance rather than an adapted clinical evaluation
- MDCG guidance applied, including 2019-9 rev 1 for SSCP and 2020-13 for the assessment report template your file will be read against
CER without an approved planRaised first
State of the art not documentedSecond most common
Equivalence claimed without full evidenceRarely accepted
PMCF treated as optionalRequires justification
GSPR checklist without evidence referencesChecked line by line
Plan → evaluation → report → post-market → back into the plan
- The regulation and MDCG version named in the document
- Plan written and approved before the report
- Search protocol behind every state-of-the-art claim
- Post-market obligations set by class, not by habit
- Written to the assessor’s template
Deliverables
Twelve MDR and IVDR Documents in Regulatory Sequence
The documents follow the sequence the regulation sets. A report dated before the plan it is meant to follow is a finding in itself.
MDR Annex XIV, firstMost serious CER deficiencies trace back to a plan that was written afterwards or not at all.
Against the plan’s criteriaA favourable conclusion against criteria set after the evidence was reviewed does not constitute an evaluation.
The benchmark for everything elseThe state of the art is not a literature summary. It is the standard the device must meet or exceed.
IVDR Annex XIIIThese are three separate demonstrations. Combining them is the most common structural error under IVDR.
Before your device is mentionedScientific validity concerns the biomarker, not the assay, and evidence for one is not evidence for the other.
The IVDR conclusionAn assay can perform well analytically and still lack clinical usefulness, so the report addresses both.
Or an evidenced justification“PMCF not applicable” without a documented rationale is a finding in its own right.
Frequency set by classClass IIb and III devices require a PSUR annually, class IIa at least every two years, and class I a PMS report under Article 85. We set the reporting frequency for your device class.
Two audiences, one documentThe patient version is written and validated separately, because it is read by people making decisions about their own treatment.
ISO 14971, reconciledAssessors read the risk file and the CER together, so any inconsistency between them is identified quickly.
Each requirement linked to its evidenceA checklist that cites a document not containing the evidence is treated more seriously than a gap.
For the FDA routeThe choice of predicate largely determines the strength of the submission, so we assess it first.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Four Device Regulatory Standards at Current Versions
Device standards are revised regularly. A file built on a withdrawn edition may have to be corrected at the notified body’s request, so we work to current versions.
MDR and IVDR (the regulations themselves)
Annex XIV for clinical evaluation and PMCF, Annex XIII for performance evaluation, Articles 83 to 86 for surveillance and periodic reporting.
ISO 14155:2026 (clinical investigation of devices)
The 2026 edition replaced the withdrawn 2020 edition on 23 March 2026. Protocols written to the 2020 edition need to be reconciled with it rather than reissued.
ISO 14971 (risk management)
The risk file is read alongside the clinical evaluation, and both must state the same benefit and residual risk.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
Responsible Use of AI
Our Approach to AI Use in Medical Device Regulatory Writing
Regulatory reviewers trace decisions back to evidence and to named individuals. For this reason, source traceability takes priority over speed whenever we use AI tools.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote its own accuracy figure, which would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How We Develop Your Medical Device File
The regulation sets the order of the work, so the four steps follow a fixed sequence.
Classification and Scoping
Device class, conformity route and regulation determine which of the twelve documents you need and how often each must be updated.
Clinical or Performance Evaluation Plan
We prepare the CEP or PEP with acceptance criteria specific enough that the device could fail to meet them.
State-of-the-Art Assessment
We document a reproducible search to establish the benchmark against which the rest of the file is judged.
Evaluation, Reporting and Post-Market Feedback
We prepare the report against the plan, then feed PMS and PMCF data into the next revision, because the regulations require a continuous cycle.
Our Experts
Your Medical Device Regulatory Writing Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Reviews the scientific content for accuracy and confirms that each conclusion is supported by the evidence. Each expert is matched to your field of research.
Writes the manuscript or document against the applicable reporting guideline and the target journal or funder requirements, with every statement traceable to its source.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan and that the analysis can be reproduced.
Checks the finished work independently against the agreed scope and the applicable checklist. Findings are logged and resolved before delivery.
FAQs
Medical Device and IVD Regulatory Writing FAQs
If your question is not answered here, ask an expert. No quote is required.
This is the most common serious finding we see. It cannot be corrected by backdating the plan, and we do not backdate documents.
The appropriate route is to write the plan now, with the current date, and run the next evaluation against it, disclosing the gap. Assessors handle this situation regularly.
Under MDR this requires technical, biological and clinical equivalence together, plus a contract giving you full access to their technical documentation. In practice that last condition rules it out for most manufacturers.
We advise early on whether your equivalence argument is likely to be accepted, before the file is built around it.
We prepare documents and support your responses, but correspondence with the notified body remains yours, because it is assessing your quality system and your file.
The teams overlap but are not identical. Device work is assigned to writers who work with MDR and IVDR routinely, because the frameworks differ in structure as well as terminology.
Related Services
Related Regulatory Writing Services
Services that provide evidence for a device file, and services that use the completed file.
1THE EVIDENCE BEHIND ITtwo service areas
Research servicesDesign, synthesis and statistics. Discovery and intelligenceResearch to inform product development.2THE PHARMA EQUIVALENTone service group
Regulatory writingSubmissions and study reports.3AFTER THE CE MARKtwo service areas
Market access and HEORPayer submissions, HTA and pricing. Medical communicationsField and publication work.Request a Free Device Documentation Assessment
We identify which of the twelve documents your device requires and how often each must be updated. Many manufacturers need fewer documents than expected, updated more frequently.