EU MDR · structured requirements

🇪🇺 European Union medical device regulatory data

Explore the medical device requirements currently available for European Union, organized by topic and linked to official sources.

5 facts3 dimensions2 official sourceslatest verification 2026-08-13

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

change.available-outcomes

Outcomes: Internal Documentation Only
Notification Or Administrative Update
Prior Approval Amendment Or Variation
New Registration Or New Application
Description: Manufacturer QMS and notified-body significant-change procedures are route- and certificate-specific.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

change.new-application-triggers

new device identity or conformity assessment outside current certificate/technical documentation

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

market-entry.local-role

Archetype: Manufacturer Mandated Authorized Representative
Name: EU Authorized Representative
Required For Foreign: Yes For Non EU Manufacturer
Registration Relation: Mandated Legal Operator Not Normally Product Licence Holder
Importer Relation: Separate Economic Operator
Distributor Relation: Separate Economic Operator
Combination: May Combine If Each Role Obligation Is Met

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

market-entry.representative-change

Path Code: Three Party Transition Agreement And Regulatory Updates
Fresh Registration: No Generic Fresh Product Registration
Minimum Handover: termination/start dates
outgoing label run-off arrangement
transfer of documents
confidentiality/IP
complaints and incident forwarding
EUDAMED/member-state updates
label/IFU updates
Notes: Article 12 specifies the minimum arrangement among manufacturer, outgoing AR where practicable, and incoming AR.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Which label and IFU elements, languages, symbols, and translation controls apply?

language.label-ifu-submission

Label Ifu: Member-State specific by patient/professional use and document type
Submission: Competent-authority/notified-body language rules vary
Status: Member State Specific

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

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