Contact: IVDR Guide

Service requests, incident reports and questions for authorities take other routes, set out below.

IVDR Guide covers two regulations: the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746), both directly applicable in every member state. The site explains the EU MDR and IVDR, the two EU medical device regulations, article by article.

Writing to the Editorial Team

The IVDR Guide Editorial Team reads messages sent to editorial@ivdrguide.com about the content of the site: corrections, unclear passages and questions about which article or document a statement rests on.

Send the message to editorial@ivdrguide.com with the three details listed below.

1. The URL of the page concerned.
2. The sentence or table row concerned, quoted.
3. The primary source, if you have one: the act and article, or the official document and its date.

Write in English, one topic per message. No reply time is stated.

Reporting an Error on a Page

A correction is most useful when it names the official source that shows the error: the regulation text on EUR-Lex, a Commission page, an MDCG document, a NANDO entry, the EUDAMED public site, a national gazette or a competent authority. How statements are checked against these sources is set out under methodology and fact-checking.

Each correction is checked against those same primary sources before a page changes. A statement is never changed on the strength of a secondary article alone.

Requests for Service Providers

The editorial address is not the route for service requests: a reader who needs a consultant, an EU authorised representative, notified-body preparation support, a clinical evaluation writer or CRO, training or an eQMS uses the provider match form instead.

The form asks you to describe what you need and passes the request to independent MDR and IVDR providers who work on this. The form sits with the MDR and IVDR compliance programme.

Requests go to independent providers. Providers cannot buy a place on ivdrguide.com; see our editorial policy.

What the Editorial Team Cannot Answer

The editorial team does not give regulatory advice on a named device and does not give legal advice. It does not answer whether a named product is a medical device or an in vitro diagnostic medical device, which class it falls into, or which conformity assessment route applies.

The team also gives no legal opinion, no help in a dispute with a notified body, a competent authority or a business partner, and no review of a technical file or a contract.

The pages explain instead what the MDR and the IVDR require, with the article behind each statement. Classification explanations are indicative and give the Annex VIII rule. MDCG guidance is explained as not legally binding (MDR Articles 103 and 105, IVDR Articles 98 and 99).

Official Contacts at Authorities and the Commission

Serious incidents are reported under MDR Article 87 and IVDR Article 82, not to this site, and as of 6 November 2026 the reports go through national channels because the EUDAMED vigilance module is not in use. The reporting deadlines are explained under vigilance under the MDR and IVDR.

Each member state designates its competent authorities, and the Commission publishes their contact details (MDR Article 101, IVDR Article 96). The Commission contacts page holds the list of contact points of national authorities (May 2026 edition, covering the EU 27 plus Norway, Iceland, Liechtenstein and Türkiye) and the list of vigilance contact points (September 2026 edition).

Questions about using EUDAMED go to the Commission's EUDAMED support contact, SANTE-EUDAMED-SUPPORT@ec.europa.eu.

Who Publishes This Site

IVDR Guide is published by ivdrguide.com as an independent, provider-neutral reference on the MDR and the IVDR, written by the IVDR Guide Editorial Team. Its scope is set out on the page with more about IVDR Guide.

How Your Message Is Handled

Form data are kept for 24 months, and the privacy notice sets out how messages and form data are handled.