Services / MD QMS Assure
MD QMS Assure · Quality & regulatory
EU MDR, UK MDR & EUDAMED
Market access in Europe depends on three things lining up: your technical documentation, the right economic operators in the right roles, and correct registration in EUDAMED. We check and close the gaps.
Why it matters
EUDAMED’s first four modules (Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance) became mandatory on 28 May 2026. Devices placed on the market before that date and still being sold must be registered in the UDI/Device module by 28 November 2026.
For manufacturers outside the EU, the Authorised Representative and importer roles have to be in place and correctly linked. In Great Britain, CE-marked devices remain accepted for a transition period, but non-UK manufacturers need a UK Responsible Person.
Who it’s for
- UK and other non-EU manufacturers selling into the EU
- Manufacturers with legacy devices that still need EUDAMED registration
- Companies preparing technical documentation for notified-body review
What’s included
- EUDAMED readiness check: actor registration, UDI-DI data and device registration status
- Economic-operator mapping: who acts as manufacturer, Authorised Representative, importer and distributor for each market
- Technical documentation review against EU MDR Annexes II and III, or UK MDR
- Labelling and IFU check for the markets you sell into
- Remediation plan and, where needed, introduction to our EU sister company MD QMS SRL for importer services
Deliverable
Market-access readiness pack.
Everything we write is yours to own and maintain. We stay available for auditor or reviewer questions on anything we produced.
How it works
Discover
A free 30-minute call to understand your product, markets and deadline.
Define scope
A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.
Build evidence
We do the work with your team, not around it. Everything is written for you to own.
Support delivery
We stay with you through audits, submissions and reviewer questions on anything we wrote.
Questions we’re often asked
Our Authorised Representative handles EUDAMED. Do we still need this?
The manufacturer remains responsible for its device registrations. The check confirms the data is complete and correctly linked, whoever enters it.
Can MD QMS act as our EU importer?
Our EU sister company, MD QMS SRL, is registered in EUDAMED as an importer. We keep the roles separate and will tell you plainly if one company holding more than one role would create a conflict for your devices.
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Book a free 30-minute discovery call. We’ll understand your product and deadline, and tell you exactly what an engagement would involve and cost. No obligation.