Methodology and fact-checking: IVDR Guide

The sections below set out the four source levels, the checks, the dating, pending proposals, updates and corrections that apply to every page of this reference on the MDR and IVDR.

The Order of Sources Behind Every Page

IVDR Guide ranks its sources in four levels, and a lower level never overrides a higher one: EU law, then Commission documents and the official EU registers, then national law and authorities, then secondary sources, which serve only as leads. A newer official source beats an older one, and the page is then corrected. The table sets out each level.

Sources checked as described on this page; statuses on each page carry their own "as of" date.

EU Law on EUR-Lex First

The text of the MDR and the IVDR, their amending regulations and their implementing and delegated acts is read on EUR-Lex and cited by its CELEX number and Official Journal reference. The MDR is CELEX 32017R0745 (OJ L 117, 5.5.2017, p. 1) and the IVDR is CELEX 32017R0746 (OJ L 117, 5.5.2017, p. 176). Both are regulations, directly applicable without transposition and in force since 25 May 2017 (MDR Article 123(1), IVDR Article 113(1)); amending acts are named by number, such as Regulations (EU) 2023/607 and 2024/1860.

Consolidated texts have no legal effect, so citations name the act as published in the Official Journal. Implementing acts do not amend either regulation.

Commission Guidance and the Official Registers

MDCG documents, Commission Q&As and notices are taken from the Commission's medical device pages on health.ec.europa.eu, and each is named with its issuer (the MDCG, NBCG-Med or the Commission) and its current revision. The Medical Device Coordination Group (MDR Article 103(1), IVDR Article 98) is chaired by the Commission (MDR Article 103(5)). Its guidance is not legally binding; notified bodies take it into consideration under MDR and IVDR Annex VII Section 1.6.2, so pages say an MDCG document "explains", never "must follow". Revisions come from the Commission's guidance list.

Notified-body designations come from NANDO, and EUDAMED data from the public EUDAMED site, set up under MDR Articles 33 and 34 and IVDR Article 30. A standard counts as harmonised only when cited in Implementing Decision (EU) 2021/1182 (MDR) or 2021/1195 (IVDR), each as amended.

National Gazettes and Authority Websites

National rules come from the official gazette and the competent authority's website, because the MDR and the IVDR leave member states only matters such as penalties, languages, distributor registration, reprocessing and in-house rules. One example is Germany's Medizinprodukterecht-Durchführungsgesetz (MPDG, Medical Devices Implementation Act) of 28 April 2020, BGBl. I S. 960. Authorities are named from the Commission's list of national competent authorities, May 2026 edition. A Commission per-country table never sources a current national status, and national provisions prevail over the Commission language table.

Secondary Sources as Leads Only

Consultancy articles, vendor pages, press reports and unofficial text copies can point to a new act or document, but they are never cited. Each lead is followed to the primary source; without one, the statement is not published.

How Each Statement Is Checked

Every article reference, date, number and status on a page is checked against the primary source it comes from, and a value that cannot be traced to a primary source is left out rather than written with a hedge. Articles are cited exactly as the act numbers them, always with the act named, as in "MDR Article 120(3c)" or "IVDR Article 110(3)".

No notified body, consultant or other company is presented as a choice, and no named manufacturer is told that its product is or is not a medical device, an in vitro diagnostic medical device or in a class.

How Dates and Statuses Are Dated

Dates are written out in full, and every status that can change (an EUDAMED module, a NANDO designation, a harmonised-standards list, an MDCG revision, a national law or a pending proposal) carries the date on which it was checked, written "as of" that date. A typical sentence reads: as of 6 November 2026, four of the six EUDAMED modules have been mandatory to use since 28 May 2026.

A count or an estimate keeps its own date and source, never the page's "as of" date.

How Pending Proposals Are Labelled

A legislative proposal is always written as "proposed" or "pending", with its stage and the date of that stage, and its wording is never presented as current law. The Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), for example, is pending at the stage "Awaiting committee decision" in the European Parliament, as of 6 November 2026, as its OEIL procedure file shows. Its content is written as what "the proposal would" do.

Forecast, vote and adoption dates and Council statements are left out until the procedure file shows them as past events. Every adopted act and the pending proposal are listed under MDR and IVDR amendments.

When a Page Is Updated

A page is re-checked and updated when one of six official events touches its topic, and between such events every dated status is re-checked at least once a year. The six events are listed below.

1. An amending regulation, such as Regulation (EU) 2024/1860.
2. A Commission implementing or delegated act on the MDR or the IVDR.
3. A new MDCG document or revision.
4. A Commission notice on EUDAMED, or a NANDO designation change.
5. An amended harmonised-standards list or national implementing law.
6. A new procedural step of COM(2025) 1023.

An update changes a statement and its "as of" date together. For EUDAMED, the trigger is the Commission notice: obligations for a system apply 6 months after its publication in the Official Journal (MDR Article 123(3)(d), IVDR Article 113(3)(f)).

How to Report an Error

Anyone who finds an error on IVDR Guide can report it to editorial@ivdrguide.com with the page address, the statement concerned and, where possible, the primary source that shows the correct value. Each report is checked against that source and, if right, corrected like any other update.

A request for regulatory advice on a specific device is not handled as a correction. Other questions go through the IVDR Guide contact page.

What This Methodology Does Not Cover

This method governs how facts are sourced and corrected; it is not legal advice, and two neighbouring questions are answered on their own pages. The three limits are listed below.

• Legal or regulatory advice on a specific device.
• Independence, and why providers cannot buy a place on the site: IVDR Guide editorial policy.
• The publisher of the site: about IVDR Guide.