Scope and limits. This navigator is a structural reference, not a reproduction of the legal text. Only the version of Regulation (EU) 2017/746 published in the Official Journal of the European Union is authoritative; each provision links to the consolidated EUR-Lex text. Article and annex titles follow the official English wording; the plain-language notes are our own summaries and are not a substitute for reading the provision.
How to read the mappings. A filled marker () means the instrument is cited — named in the IVDR text, listed in the Official Journal harmonisation decision against that requirement, or scoped to that provision by the instrument itself. An open marker () means it is applied — our professional judgement of what a notified body would expect to see. Applied mappings are analytical, not legal cross-references, and should be justified in your own technical documentation.
Exports. Export scope produces a standalone HTML document of whatever is currently filtered, ready to print to PDF; hold shift for CSV instead. The GSPR checklist tab builds an Annex I checklist from a device profile, pre-filled with the standards and guidance that apply to each section, with empty columns for method of conformity and evidence reference, and a justification column on every section the profile rules out. Annex II Section 4 requires those justifications; the export leaves the space and the reasoning to you.
Sharing a view. The address bar tracks what you are looking at — mode, search, class, coverage filter and the provision you jumped to. Copy the URL and it opens in the same state for whoever you send it to. That is how a reference tool travels.
Opening the documents. EUR-Lex, MDCG, IMDRF and GHTF material is freely reusable and links directly to the document. ISO, IEC, CEN and CLSI documents are licensed per user; there is no free full text to link to and no per-document URL derivable from a designation, so those resolve through each body's own search. If you hold licensed copies, set LINKS.localBase at the top of this file to your PDF folder and every entry gains an Open local PDF button. Leave it empty for anything published on a website — serving licensed standards from a public folder breaches the licence. Run pdfManifest() in the browser console for the expected filename list.
IMDRF and GHTF. Neither has legal standing in the Union. Nothing here is cited in the Official Journal, so nothing confers presumption of conformity, and unlike MDCG guidance these are not even the EU's own interpretation. GHTF dissolved in 2012 and its documents are archived, not maintained. They earn their place for two other reasons. Documents marked with a teal edge are direct ancestors of the provision they map to — the Annex XIII performance evaluation triad is GHTF/SG5/N6, N7 and N8; the Annex VIII classes descend from GHTF/SG1/N45; the Annex II structure is the STED of GHTF/SG1/N63. And the IMDRF IVD Table of Contents is the practical route to one technical file serving several markets. One document does carry operational weight in the Union despite all of the above: the IMDRF adverse event terminology supplies the codes used on the EU Manufacturer Incident Report form.
Definitions. The 74 defined terms of Article 2 are reproduced in full, from the consolidated text 02017R0746 — EN — 10.01.2025 — 005.001 retrieved from EUR-Lex on 22 July 2026. Defined terms are underlined wherever they appear in a provision summary; click one to read the definition without losing your place. The full list is under Definitions in the toolbar and on the Article 2 card. Definitions matter more here than they look: the difference between performance of a device, analytical performance, clinical performance and performance evaluation is four separate legal concepts that a technical file has to keep apart.
Designations. Presumption of conformity attaches to the reference the Commission publishes in the Official Journal, which is the EN adoption. Its year frequently differs from the ISO edition year — EN ISO 17511:2021 adopts ISO 17511:2020; the EN ISO 18113 series is dated 2024 against ISO originals of 2022. Citing the ISO designation in a declaration of conformity or a GSPR checklist claims compliance with a standard that is not the harmonised one. Entries where the two diverge carry an amber edge and a designation check; filter for them under coverage. The reverse case exists too: where ISO has issued a newer edition that the Official Journal has not yet cited, adopting it forfeits presumption until the citation catches up.
Developer or user. CLSI documents are marked by addressee. Developer means the manufacturer establishes the claim — that is what belongs in Annex II and Annex XIII. User (shown with a dashed outline) means the laboratory verifies the manufacturer's claim on its own instruments, which is EN ISO 15189 and Article 5(5) territory. The distinction is not cosmetic: a technical file that cites EP15 to establish precision has cited a user-verification protocol where an establishment protocol was required. CLSI marks this split explicitly in its newer companion guides — EP06IG is the user path, EP06EG the developer path for the same parent.
Currency. Harmonised standards reflect the Commission summary list for Regulation (EU) 2017/746 generated 17 June 2026, consolidating Implementing Decision (EU) 2021/1195 and its amendments through (EU) 2026/1313. MDCG guidance reflects the Commission guidance page as at 21 July 2026. CLSI editions change independently of this document — confirm the current edition at clsi.org before citing one in a technical file. ISO and IEC standards, CLSI guidelines and common specifications are the copyright of their respective bodies; only designations, titles and scope descriptions are reproduced here.
Copyright and licence. © Dr. Patel Consulting, Ober-Ramstadt, Germany. The mapping dataset, the L1–L5 evidentiary grading, the cited-versus-applied distinction and the class applicability model are original work. You may use this tool and its exports for your own internal purposes and you are welcome to link to it. Republishing it as your own resource, or stripping the attribution from an export, is not permitted. Underlying legal texts, standards designations and guidance titles remain the property of their respective bodies as set out above.
Build 2026-08-19. A regulatory reference decays. Check the build date against today before relying on anything here, and check ivdr.drpatelconsulting.com for the current version. Reference tool, not regulatory advice.
Site notices. Impressum · Datenschutzerklärung · Contact. This page sets no cookies and loads no third-party resources — every font, style and script is served from this domain.