About: IVDR Guide

This page sets out who the site serves, what it covers, which primary sources it relies on, how it is funded, why providers cannot buy a place on it and how to reach the editorial team.

What This Reference Is

IVDR Guide explains what the MDR and the IVDR require, for whom and by when, with the article of the act behind every statement. Both acts are regulations, in force since 25 May 2017 (MDR Article 123(1) and IVDR Article 113(1)) and directly applicable in every member state, with no transposition. National laws implement only what the two regulations leave to member states, such as penalties and language rules. Each page therefore starts from the framework set out under EU MDR and IVDR.

The MDR has applied since 26 May 2021 (MDR Article 123(2), as amended by Regulation (EU) 2020/561), and the IVDR has applied since 26 May 2022 (IVDR Article 113(2)). The site is written in English for readers worldwide.

Who the Site Is For

The site is written for the people who have to apply the two regulations day to day: manufacturers, PRRCs, laboratories and health institutions, importers and non-EU manufacturers selling into the EU. Authorised representatives and distributors use the same pages. The five audiences and their starting pages are listed below.

• Device and IVD manufacturers: the manufacturer obligations of MDR Article 10 and IVDR Article 10.
• PRRCs: the role of the person responsible for regulatory compliance under MDR Article 15 and IVDR Article 15.
• Laboratories and health institutions making devices for their own use: in-house devices under MDR Article 5(5) and IVDR Article 5(5).
• Importers: the importer obligations of MDR Article 13 and IVDR Article 13.
• Manufacturers outside the EU: non-EU manufacturers need an EU authorised representative under MDR Article 11 and IVDR Article 11.

What the Site Covers

IVDR Guide covers everything the MDR and the IVDR require of a device, an IVD or an operator, from classification and conformity assessment to post-market duties, and stops where the two regulations stop. The coverage also takes in the amending regulations, the implementing and delegated acts, EUDAMED, notified bodies and the guidance of the Medical Device Coordination Group (MDCG), set up under MDR Article 103 and IVDR Article 98, which explains the rules and is not legally binding. The targeted revision of both regulations is reported as a proposal only: pending, Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), listed as "Awaiting committee decision" in the European Parliament as of 6 November 2026, and not law. The seven coverage areas are listed below.

• EU MDR (Regulation (EU) 2017/745): the medical device regulation.
• IVDR (Regulation (EU) 2017/746): the in vitro diagnostic regulation.
• EUDAMED: the European database on medical devices under MDR Articles 33 and 34 and IVDR Article 30.
• MDCG guidance: the documents that explain how both regulations apply in practice.
• MDR and IVDR by country: the national implementing laws and authorities of the 27 member states, with one page each for Switzerland and the United Kingdom.
• MDR and IVDR compared: four comparisons, MDR vs IVDR, MDD vs MDR, IVDD vs IVDR and EU MDR vs FDA.
• MDR and IVDR amendments: the amending regulations and the pending revision.

Where the Information Comes From

Every page is compiled from primary sources and checked against them: EUR-Lex for the regulations and their amendments, the European Commission's medical device pages, MDCG documents, NANDO, EUDAMED, national gazettes and the competent authorities. The official texts are the MDR on EUR-Lex and the IVDR on EUR-Lex; MDCG documents from the Commission's MDCG guidance list, notified-body designations from NANDO and database content from the EUDAMED public site. Secondary sources, such as consultancy blogs, vendor pages and press reports, are never the basis of a statement, and a value that cannot be confirmed in a primary source is left out.

Values that change, such as EUDAMED module status, MDCG revisions, national laws and the pending proposal, carry the date on which they were checked. How pages are checked and corrected is set out under methodology and fact-checking.

How the Site Is Funded

IVDR Guide is free to read and is funded by provider match requests. Topic pages invite readers to describe a need under the line "Describe what you need and we pass your request to independent MDR and IVDR providers who work on this." The request is then passed on to independent providers, such as regulatory consultants, EU authorised representatives, notified-body preparation support, clinical evaluation writers and CROs, training providers and eQMS vendors.

The site carries no advertising, no paid articles and no sponsored rankings.

Independence from Providers

Providers cannot buy a place on ivdrguide.com: no payment changes what a page says, which sources it cites or whether a company is mentioned. The site names and ranks no notified body, consultant, CRO, eQMS vendor or manufacturer as a choice; the rules behind this are set out in the editorial policy.

IVDR Guide is not part of any authority, notified body, manufacturer or provider, and its pages are not official guidance. For the binding text of the MDR and the IVDR, the reader goes to EUR-Lex.

What the Site Does Not Do

IVDR Guide explains the regulations; it does not give legal or regulatory advice, and it never tells a named manufacturer whether its product is a medical device, an IVD or in a given class. It does not cover non-EU regimes beyond Switzerland, the United Kingdom and the FDA comparison, medicines law or reimbursement.

How to Reach the Editorial Team

Questions, corrections and comments go to the editorial team at editorial@ivdrguide.com. A reported error is checked against the primary source and corrected on the page. The two pages for contact and data are listed below.

• The contact form, for questions and corrections.
• The privacy page, on what happens to data sent to the site.