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Editorial Policy: IVDR Guide

How IVDR Guide stays independent: no paid placement, how provider requests work, primary MDR and IVDR sources, corrections and language policy.

Last updated 12 November 2026 · By the IVDR Guide Editorial Team · How we fact-check · Print this page

Summary

IVDR Guide is an independent, provider-neutral reference on the two EU medical device regulations, the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746), and this editorial policy sets out how its content stays free of paid influence.

Its seven sections cover scope, independence, provider-match requests, indicative information, primary sources, corrections and languages. IVDR Guide is published at ivdrguide.com by the IVDR Guide Editorial Team.

Scope of the Reference and Its Readers

IVDR Guide explains what the MDR and the IVDR require, for whom and how to meet it, together with their amending regulations, implementing acts, MDCG documents, EUDAMED and the national implementing laws. Both acts are regulations, directly applicable in every member state without transposition. National laws implement only what the two regulations leave to member states, such as penalties, languages and the registration of distributors.

Its readers are regulatory affairs and quality managers at device and IVD manufacturers (non-EU ones included), importers, distributors and health institutions making in-house devices. How the two regulations fit together is set out under the EU MDR and IVDR overview.

The two regulations have one reference hub each, listed below.

Independence and No Paid Placement

No provider, notified body, manufacturer or other company can pay for a mention, a ranking, a link or a change to any page of IVDR Guide. The editorial team alone decides page content, against the primary sources. IVDR Guide carries no sponsored content and no advertising.

IVDR Guide never names or ranks a notified body, consultant, clinical research organisation (CRO), electronic quality management system (eQMS) vendor or manufacturer as a choice. A notified body appears only as a dated NANDO register entry (name and number) on pages holding NANDO data. Prices appear only as dated public-record values or ranges or as quote factors, never as current prices.

How Provider-Match Requests Work

On many pages a short form invites readers to describe what they need, and IVDR Guide passes that request to independent MDR and IVDR providers who work on the topic. The form reads: "Describe what you need and we pass your request to independent MDR and IVDR providers who work on this." The six kinds of providers a request can reach are listed below.

  • Independent regulatory consultants
  • EU authorised representatives
  • Notified-body preparation support
  • Clinical evaluation writers and CROs
  • Training providers
  • eQMS vendors

Under every form sits this disclosure: "Requests go to independent providers. Providers cannot buy a place on ivdrguide.com; see our editorial policy." A request passed to a provider buys that provider no mention, creates no influence on content and changes no page. The form gives no legal or regulatory advice and promises no certificate, no notified-body acceptance, no response time and no number of replies. The privacy notice sets out how request data are kept, and where requests fit into the MDR and IVDR compliance programme is explained step by step.

Indicative Information, Not Advice to a Named Manufacturer

IVDR Guide explains how the MDR and the IVDR apply to kinds of devices and roles, and it never tells a named manufacturer that its product is or is not a medical device, an in vitro diagnostic medical device or in a given class.

Every statement carries its legal basis, cited with the act and article ("MDR Article 120(3c)", "IVDR Article 110(3)"), so readers can check it in the regulation itself. The decision for a specific product rests with its manufacturer and, where a notified body is involved, with that body's conformity assessment.

The class finder gives an indicative class only, with the MDR or IVDR Annex VIII rule behind each answer, and the medical device class finder works step by step through those rules.

Primary Sources and How Content Is Checked

Content on IVDR Guide is compiled from named primary sources and checked against them, and every value cites the source it comes from. The seven kinds of primary sources are listed below.

  • EUR-Lex: the MDR and IVDR texts, amending, implementing and delegated acts, proposals
  • Commission medical device pages on health.ec.europa.eu
  • MDCG documents on the Commission's guidance list
  • NANDO, for notified-body designations
  • The EUDAMED public site
  • National gazettes, for national implementing laws
  • National competent authorities

Where a newer official text differs from an earlier one, the newer text wins. Statuses that change carry an "as of" date: EUDAMED module statuses, NANDO data, harmonised-standards lists, MDCG revisions, national laws and pending proposals. A standard is called harmonised only together with its Implementing Decision, (EU) 2021/1182 for the MDR and (EU) 2021/1195 for the IVDR, each as amended.

MDCG documents are not legally binding, as the Commission's guidance list states. Notified bodies "shall take into consideration guidance and best practice documents" (MDR and IVDR Annex VII Section 1.6.2), so IVDR Guide writes that an MDCG document "explains", never "must", and names its current revision. Each document is listed by topic under MDCG guidance.

Corrections Policy

Readers who find an error report it to editorial@ivdrguide.com with the page address, the value in question and, where possible, the primary source showing the correct value.

A reported value is checked against the primary source; when the source confirms the report, the page is corrected and cites it. A pending proposal stays labelled pending: COM(2025) 1023 (procedure 2025/0404(COD)) was proposed by the Commission on 16 December 2025 and is at "Awaiting committee decision" in the European Parliament as of 6 November 2026 (procedure file on OEIL); no page presents its wording as current law.

Eight kinds of official events lead to a page update, listed below.

  • An amending regulation
  • An implementing or delegated act
  • An MDCG revision
  • A EUDAMED notice
  • A NANDO change
  • A harmonised-standards decision
  • A national law amendment
  • A procedural step of a pending proposal

Language Policy: English First, German Edition Later

IVDR Guide publishes in English first, and a German edition follows later. The English text uses British (EU) spelling as in the English versions of the regulations ("authorised representative", "harmonised", "labelling") and keeps official names unchanged, with an English gloss for German or other legal terms.

Four other pages complete this policy: who publishes IVDR Guide, how its facts are checked, how to reach the editorial team and how personal data are handled. Questions about this policy go to editorial@ivdrguide.com. The four pages are listed below.

Sources