GSPR Checklists and Technical Documentation for Device Manufacturers
Pubrica prepares GSPR checklists and technical documentation for medical device manufacturers. A Notified Body starts its review with the GSPR checklist, and this is where most technical documentation is found deficient. For every applicable requirement in MDR Annex I, the checklist names the standard or common specification used to meet it and gives a reference to the document and section that contains the evidence, rather than a document title or a general reference to the technical file. Our device regulatory writers prepare each row so that an assessor can reach the evidence in one step.
- Evidence referenced to document and section, because an assessor who cannot find the evidence records it as absent
- Non-applicability justified individually, because a requirement marked not applicable without a device-specific reason is a finding
- Harmonised standards and common specifications named with versions, including requirements met by another route, with the route explained
- Technical documentation structured to Annex II, so that the file is complete and easy to navigate
- Cross-checked against the CER, the risk file and the SSCP, because the checklist refers to all of them and any inconsistency is visible
Every applicable requirement addressedIncluded
Evidence cited to document and sectionIncluded
Non-applicability justified individuallyIncluded
Annex II structure appliedIncluded
Citing evidence that does not existNot offered
Annex I → applicable → method → evidence → located
- Every applicable requirement addressed
- Evidence cited to section, not to a title
- Non-applicability justified per requirement
- Standards named with versions
- Cross-checked against the file
Deliverables
Four Core Elements of Every GSPR Checklist
The GSPR checklist is a navigation document. Its purpose is to take an assessor from each requirement to the supporting evidence in one step.
From the checklist10.1 Biocompatibility — see Technical File10.1 Biocompatibility: met via EN ISO 10993-1:2020. Evidence: Biological Evaluation Report BER-004 v3.0, sections 6.2 to 6.5, and test reports TR-118, TR-119. Cytotoxicity, sensitisation and irritation addressed; systemic toxicity justified as not applicable in BER-004 section 7.
From the reviewRequirements for devices incorporating a medicinal substance do not apply to most devices. A one-line justification per requirement avoids the question that a blank column would generate.
From the standards listThe harmonisation status of standards under the MDR has changed considerably since 2017. Citing a standard whose harmonisation status has changed, or a superseded version, is a common and avoidable finding.
From the structure reviewAssessors work to fixed timelines. A complete file that is difficult to navigate generates more questions than a smaller, well-organised one, and each question adds weeks to the review.
All samples are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Four Governing Standards and Guidelines for GSPR Checklists
Annex I sets out the requirements you must meet, and Annex II sets out how the evidence must be presented.
Medical Device Regulation (the regulation itself)
Article 32 for the SSCP, Articles 83 to 86 for post-market surveillance, Annex I for the general safety and performance requirements, Annex II for technical documentation and Annex XIV for clinical evaluation and PMCF.
Risk management for devices (with ISO/TR 24971:2020)
Defines risk management as a lifecycle process: hazard identification, risk estimation and control, overall residual risk acceptability, and the feedback of production and post-production information into the file.
Clinical evaluation guidance (June 2016)
The structure that Notified Bodies still assess against, read alongside MDCG 2020-13, which is the assessment template that assessors use.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Governs how each project is run, recorded and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to evidence and to a responsible individual. Our specialists therefore treat source traceability as more important than speed, and every statement in a document must be supported by a traceable source.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
For this reason, Pubrica does not quote an accuracy figure of its own, as it would carry the same conflict of interest. We tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our GSPR Checklist Writing Process Works
We assess applicability first, because a requirement that genuinely does not apply needs only a justification, and that justification must be accurate.
Applicability assessment
Every Annex I requirement is assessed for applicability to the device and its intended purpose, and the reason is recorded in either case.
Method
For each applicable requirement, we name the harmonised standard, common specification or other route used to meet it, with its version.
Evidence referencing
We identify the document, version and section that contain the evidence, and where no evidence exists, we record the gap.
Structure and cross-check
The technical documentation is organised to Annex II, and the checklist is cross-checked against the CER, the risk file and the SSCP.
Our Experts
Our Medical Device Regulatory Writing Team
The same named team of regulatory specialists works on your project from scoping to delivery, and your project coordinator introduces each member before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. The expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Three GSPR and Technical Documentation Service Packages
Cost depends on device class and, above all, on the state of the evidence that the checklist must reference.
GSPR checklist
A device with evidence in place
Quoted per projectOn class and requirement count
Delivery By scope
- ✓Applicability assessed per requirement
- ✓Standards named with versions
- ✓Evidence cited to document and section
- ✓Non-applicability justified individually
- ✓Gaps recorded where evidence is absent
The gap list is often the most valuable output, because it shows you the likely Notified Body findings before submission.
Deliverables Request a quoteTechnical documentation build
Assembling or restructuring the file
Quoted per projectOn class and document count
Delivery By scope
- ✓Annex II structure applied
- ✓Document numbering and version convention
- ✓GSPR checklist as the navigation layer
- ✓Cross-references checked to resolve
- ✓Consistency across CER, risk file and SSCP
At assessment, a navigable file is more valuable than an exhaustive one, because assessors work to fixed timelines.
Deliverables Request a quotePre-submission gap analysis
Before the notified body sees it
Quoted per projectOn file size
Delivery By scope
- ✓Checklist tested reference by reference
- ✓References followed to confirm they resolve
- ✓Standard versions and harmonisation checked
- ✓Inconsistencies across documents identified
- ✓Findings ranked by likely severity
Each issue you identify before submission is one the Notified Body does not need to raise, and you can address it without a response deadline.
Deliverables Request a quoteSend us your GSPR checklist and we will check twenty randomly selected references free of charge, to see whether they lead to the actual evidence. This is the test an assessor applies.
FAQs
GSPR Checklist and Technical Documentation FAQs
If your question is not answered here, ask an expert. No quote is required.
Document identifier, version and section. An assessor should reach the evidence in one step from the checklist.
References to a document title alone, or to “the technical file”, are the most common finding and the easiest to correct before submission.
Yes, with a reason specific to your device and its intended purpose. Many Annex I requirements genuinely do not apply to a given device.
A blank cell or an unexplained “N/A” generates a question for each requirement, so a one-sentence justification is worth including.
This is permitted. You state the route you used instead and show that it meets the requirement, which carries a higher evidence burden than claiming presumption of conformity.
Where a harmonised standard exists and you have not used it, the assessor is likely to ask about this first.
The structure is the same but the requirements are IVDR Annex I, which differ substantially, and the technical documentation follows IVDR Annex II.
An MDR checklist reused for an IVD is identified immediately, because the requirement numbers do not correspond.
Related Services
Related Medical Device Regulatory Writing Services
The GSPR checklist refers to every other document in the technical file.
1REFERENCED EVIDENCEthe evidence
Clinical evaluation reportClinical evidence. Device risk managementISO 14971 file.2TECHNICAL FILEsame submission
Technical file and 510(k)EU and US in parallel. SSCPThe published summary.3POST-MARKET DOCUMENTSkeep the file current
PMS and device PSURArticles 83 to 86. PMCF plan and reportAnnex XIV Part B.Request a Free Check of Twenty GSPR Evidence References
An assessor checks whether references lead to actual evidence, and this check can be completed quickly.