How to verify a regulatory consultant's EUDAMED track record

When you hire an external regulatory-affairs consultant — an outsourced Person Responsible for Regulatory Compliance (PRRC), a fractional QA/RA lead, a submission specialist — you cannot look them up by name in EUDAMED. The European Database on Medical Devices publishes organisations, not a searchable roster of professionals; an individual's name is simply not a search field. But you can do something better than read a CV: verify the work. The companies, SRNs, devices and notified-body certificates a consultant says they handled are all in the public record, and you can cross-check every one of them.

As of June 2026, MD Atlas has indexed 40,848 EUDAMED actors — an indexed subset of the public data, not the complete database — broken down into 25,807 manufacturers, 10,828 importers, 2,785 authorised representatives and 1,428 system/procedure-pack producers. Every one is searchable by SRN, role and country, which is exactly what makes a consultant's claimed experience checkable in minutes rather than taken on faith.

Why you verify the work, not the person

EUDAMED's actor module is built around economic operators. Under Article 30 of the MDR (Regulation (EU) 2017/745), the Commission runs the electronic system that registers manufacturers, authorised representatives and importers; Article 31 is where each of them submits its data and receives a SRN (Single Registration Number) once a competent authority validates it. That registration data is, by Article 31(7), accessible to the public — which is why the actor registration module lets anyone search organisations by name, role, country or SRN.

What it does not offer is a way in by person. There is no "find every device this consultant registered" query, because the public search axes are the organisation, the SRN, the role and the country — never an individual. So the honest, reliable approach is to start from the companies a consultant names and confirm the footprint those companies actually have.

The external-PRRC context

This matters most for the role that drives a lot of consultant hiring. Under Article 15 of the MDR, every manufacturer must have a Person Responsible for Regulatory Compliance, qualified either by a relevant degree (law, medicine, pharmacy, engineering or another relevant scientific discipline) plus one year of regulatory-affairs or quality-management experience, or by four years of such experience. Crucially, micro and small enterprises are not required to have the PRRC within their organisation — they must instead have such a person "permanently and continuously at their disposal." That single clause is why a freelance PRRC is a legitimate, common arrangement for SMEs — and why being able to vet one matters.

A four-step verification workflow

When a consultant says "I handled the EUDAMED registration and certificates for this manufacturer," check it:

1. Find the company. Search the registered actors for the manufacturer's name and open the record. Note the SRN and confirm the role — is it actually a manufacturer, or an authorised representative or importer? The role is encoded in the SRN itself.
2. Check the devices. Review the devices registered under that company, the risk classes, and the EMDN categories. Do they match the kind of work the consultant describes — a Class III submission, an IVD portfolio, a software device?
3. Check the certificates. Open the notified-body certificates behind the higher-risk devices and read each one's type, scope, validity dates and status (valid, suspended, withdrawn or expired). A consultant who claims to have steered a certification should be able to point you at a real, live certificate.
4. Cross-reference scope and timing. Line the public footprint up against the consultant's claimed projects and dates. Consistency is corroboration; contradictions are a prompt to ask better questions.

What the record can — and can't — tell you

Be honest about the limits. The public data shows a company's footprint, not who inside or outside that company did the work. EUDAMED will confirm that a manufacturer is registered, that its devices are on the record, and that its certificates stand — it will not, by itself, attribute that registration to a named consultant. So use the public record to corroborate a claim, not to prove authorship: a consultant whose named clients all check out, with devices and certificates matching their described scope, is a very different proposition from one whose references dissolve the moment you search the SRN.

This corroboration is exactly what MD Atlas's verified directory of QA/RA professionals automates — cross-matching a professional's profile against the EUDAMED actors of record, so the verification step is done before a manufacturer ever reaches out. Whether you use the directory or run the four steps by hand, the principle is the same: in a market this regulated, a regulatory professional's best reference is the public record their work leaves behind. Every figure here links back to the underlying EUDAMED entry, read against that indexing scope, and for the authoritative position the Commission's EUDAMED portal remains the reference.