European Union · Annex I (MDR)
GSPRs Mapping — Annex I Traceability
We deliver a Notified-Body-ready GSPR matrix that maps each Annex I General Safety and Performance Requirement (GSPR) to your existing Technical Documentation (TD) with concise rationales. Applicable clauses show requirement → evidence → rationale; “not applicable” (NA) items are explicitly justified. Cross-links into your TD give Notified Bodies a clean line-of-sight through Annex I during conformity assessment.
Reviewer-friendly traceability
NA justifications
Cross-links into TD
Gap visibility
How the GSPR mapping works
f you manufacture, develop, relabel, or import medical devices in the U.S., registration and listing are not optional—they are required under 21 CFR Part 807 and must be kept current.
- Collect docs → TD index, evidence list, standards, NB feedback.
- Draft clause mapping → Annex I clauses marked applicable / NA with initial evidence links.
- Review NA → Tighten and document NA justifications.
- Cross-link evidence → Insert references/hyperlinks into your TD set.
- Handover → Final matrix, gap log, and submission brief for NB use.
How the GSPR mapping works
What You Will Receive
GSPR Matrix (Annex I)
- Applicability per GSPR clause (Y/NA).
- Evidence references for applicable clauses (document IDs, sections).
- Concise rationale for how the requirement is met.
- Explicit NA justifications where a clause does not apply.
Cross-references into Technical Documentation (Annex II)
- References to TD sections, reports, and files (Annex II structure).
- Hyperlink-ready IDs/paths for use in your document management system.
- Consistent naming so the matrix and TD stay aligned over time.
Gap Log & Submission Brief
- Gap log listing missing or weak evidence per GSPR clause.
- Priority tags and suggested internal owners to close each gap.
- Short submission brief aligned with your route (Annex IX/X/XI) for NB discussions.
Included: mapping and rationales, NA justifications, cross-links, gap log, submission brief. Not included: authoring new test/clinical/risk documents, label artwork, laboratory testing, acting as a Notified Body.
Maintenance mini-plan
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
Change log & approvals note
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
Scope: Consulting and documentation only. We do not act as a notified body, importer, or legal counsel. We cannot create a complete RMF in isolation—we rely on your device knowledge, policies, and evidence. The Legal Manufacturer reviews, supplements where needed, and signs the RMF.
Why Teams Choose Sobel for Independent ISO 10993-1 Gap Reviews
Sobel acts as a critical, precise external reader for your biological evaluation documentation—focusing on how reviewers interpret your files, not on selling generic tools.
- Independent perspective on how your dossiers align with the ISO 10993-1:2025 biological effects view and ISO 14971-style risk estimation.
- Tight focus on one outcome: a concise, prioritized gap report—not templates, scorecards, or ready-made drafts.
- Strong emphasis on how chemistry (ISO 10993-18) and toxicological risk assessment (TRA, ISO 10993-17:2023) support sufficiency judgments.
- Clear explanations of where rationales are robust, weak, or missing, written in reviewer-oriented language.
- Experience across multiple markets (EU, FDA, Brazil and others), reflecting how authorities frame ISO 10993-1 within the broader risk-management process.
Our process
We move from a clear inventory of your activities and products to a repeatable registration and listing routine.
Collect
- You provide intended purpose and claims, classification rationale, TD index/evidence list, applied standards, and any existing NB feedback.
Map
- We build the initial Annex I matrix (clause-by-clause), mark applicability, and link each applicable requirement to your current evidence with concise rationales.
Tighten
- We review and refine NA decisions, document short NA justifications, and align references and terminology with your TD set and standards.
Handover
- You receive the finalized GSPR matrix, cross-reference structure, gap log, and submission brief ready to integrate into your Technical Documentation and NB submissions.
What We Need From You
We rely on you for facts about your business and devices; we provide structure and guidance.
- Intended purpose and key claims for the device.
- Classification rationale and chosen conformity assessment route (Annex IX/X/XI).
- TD index and evidence list (risk files, testing, clinical data, IFU, labelling), including file locations/IDs.
- List of applied standards and guidance documents.
- Any existing Notified Body feedback you want reflected in the mapping.
Consulting and mapping service only. We: map Annex I GSPRs to your Technical Documentation, provide rationales and NA justifications, create cross-links, and supply a gap log plus submission brief.
We do not author new test, clinical, or risk documents, do not design label artwork, do not perform laboratory testing, and do not act as a Notified Body.
FREQUENTLY ASKED QUESTIONS
Annex I conformity is mandatory; a GSPR matrix is not explicitly prescribed, but a matrix-style traceability tool is a widely used, reviewer-friendly way to demonstrate requirement → evidence mapping and support Annex II expectations for clear, organised, and searchable Technical Documentation.
No. We work with the documentation you already have or are finalising. Our scope is to map, rationalise, justify NA decisions, and cross-link Annex I to your existing evidence—not to generate new studies or core documentation.
Where helpful, we reference the applied standards and key guidance documents in the matrix and rationales, so Notified Bodies can see how your evidence and risk controls align with recognised state-of-the-art expectations.
Short Glossary
- Owner/Operator (O/O): The legal entity account used to access FURLS and manage registration and listing information.
- FURLS (FDA Unified Registration and Listing System): FDA’s online account system for registration and listing.
- DRLM (Device Registration & Listing Module): The FURLS module used specifically for medical device establishment registration and device listing.
- Initial registration & listing: The first registration and listing for a device establishment, required within 30 days of starting device activities.
- Annual review (Oct–Dec): The required yearly period to verify and update registration and listings and pay the establishment registration user fee.
- Not approval: A reminder that registration and listing do not equal FDA approval or clearance.
Build my Risk Management File
If your Technical Documentation is in place but your Annex I traceability is not, a clear GSPR matrix can be the difference between smooth review and prolonged questions. We structure requirement → evidence → rationale, document NA decisions, and highlight gaps—so your Notified Body sees exactly how Annex I is met.
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