For Medical Device & IVD
Pubrica prepares the clinical and technical documentation that medical device and IVD manufacturers submit for notified body assessment under MDR and IVDR. Our services cover clinical and performance evaluation, PMCF, post-market surveillance and PSUR, the SSCP, the risk management file and the GSPR checklist. We write the clinical evaluation plan before the report, use the state of the art as a benchmark, and treat PMCF as presumed to apply, across twelve document types written to what notified bodies assess against.
- Evaluation plans as well as reports — CEP under MDR Annex XIV Part A and PEP under IVDR Annex XIII Part A, which decide what the reports are allowed to conclude
- IVDR’s three pillars evidenced separately: scientific validity, analytical performance and clinical performance
- PMCF presumed to apply, because "not applicable" without a device-specific justification is the sentence that generates the deficiency
- The right post-market document for your class: PMSR for class I, PSUR for IIa, IIb and III — annually for IIb and III, at least every two years for IIa
- ISO 14155:2026, which replaced the withdrawn 2020 edition on 23 March 2026
Clinical and performance evaluationIncluded
PMCF, PMS and device PSURIncluded
SSCP for implantable and class IIIIncluded
Risk file and GSPR checklistIncluded
Unsupported PMCF exemptionsWe will not draft that
Plan → evidence → report → assessed → post-market
- Plans written before reports
- Current MDCG templates applied
- Superior alternatives included
- Searches recorded for the next update
- Consistency across the whole file
Our Services
Device Documentation Services in Regulatory Order
Most device deficiencies result from incorrect sequencing, such as a report written before the plan or a benchmark set after the evidence was gathered.
Why the plan comes firstAcceptance criteria that exactly match the results indicate a plan written after the data, and the plan is dated.
The most common IVDR findingPlans often treat scientific validity as an introduction rather than an evidenced pillar. Strong analytical performance does not establish that the analyte relates to the condition.
Reporting by device classClass I produces a PMSR under Article 85. Class IIa, IIb and III produce a PSUR under Article 86 — IIb and III at least annually, IIa at least every two years.
Traceable evidenceIf an assessor cannot follow a reference to the evidence in one step, the evidence is recorded as absent, so clear cross-referencing has regulatory consequences.
Samples are illustrative and anonymised. Hover any one of them to play it again.
Compliance and Standards
Device Regulations and Standards We Apply
The regulations set the obligations, and the MDCG guidance documents set what notified bodies assess.
Medical Device Regulation (Articles 32, 83-86, Annexes I-XIV)
Article 32 for the SSCP, Articles 83 to 86 for post-market surveillance, Annex I for the general safety and performance requirements, Annex XIV for clinical evaluation and PMCF.
In Vitro Diagnostic Regulation (Annex XIII)
Performance evaluation on three pillars, each evidenced separately and each feeding the performance evaluation report.
Risk management for devices (with ISO/TR 24971:2020)
A lifecycle process rather than a document, with production and post-production information feeding back into the file and an overall residual risk evaluation as its own judgement.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
How It Works
How a Device Documentation Project Works
We work in regulatory order, because work done out of order causes deficiencies.
Class and route
We establish the classification, intended purpose and applicable annexes, which determine every document you need and how often it is updated.
Evaluation plans
The clinical or performance evaluation plan is written first, with acceptance criteria derived from the state of the art rather than from your data.
Evidence and reports
Literature is searched and recorded reproducibly, evidence is appraised against the stated criteria, and reports are written to the MDCG templates.
Post-market
PMCF and PMS are set up to close the gaps the evaluation identified, on the cycle your class requires, with findings fed back into the file.
FAQs
Questions from Device and IVD Manufacturers
If your question is not answered here, ask an expert — no quote is required.
Only with a specific, device-level justification. MDR presumes PMCF applies, and a general statement about long market history or low risk class is not a justification.
Where PMCF does not apply, we will write the justification. Where it does apply, an exemption would only move the problem to the notified body review.
No, although the similar names cause confusion. The EU RMP is a pharmacovigilance document under GVP Module V, whereas the device risk management file is an ISO 14971 engineering and safety record.
They involve different regulations, content and reviewers. We provide both and keep them distinct.
Yes. State of the art is the current standard for the indication, whatever your device does relative to it.
The assessor searches the same literature, and an omission of this kind affects how the rest of the evaluation is read.
ISO 14155:2026, which replaced the withdrawn 2020 edition on 23 March 2026.
Documents that still cite the 2020 edition cite a withdrawn standard, which assessors notice immediately.
Related services
Related Audiences and Services
Related services for pharma, payer and evidence work.
1IF YOU ARE PHARMAdifferent regulation
Pharma and biotechICH, CTD, GVP and HTA. Regulatory writingThe pharma document set.2THE PAYER STAGEafter approval
Market access and HEORHTA and reimbursement. Health economicsThe economic case.3SUPPORTING EVIDENCEbuilt first
State-of-the-art reviewThe clinical benchmark. Systematic reviewThe underlying search method.Request a Free Review of Current Alternatives for Your Device
Send your intended purpose and we will identify the current alternatives, so you can see the benchmark your device will be measured against before you commission any work.