Everything you need to know about EU MDR compliance, CE marking, EUDAMED registration, and working with NordMDR AB.
Yes — if your company is established outside the European Union and you want to sell medical devices in Europe, you are legally required to appoint an EU Authorized Representative under EU MDR 2017/745 Article 11. This applies to manufacturers from the USA, UK, China, Japan, India, Australia, Canada, and every other non-EU country. There are no exceptions.
Yes. One EU Authorized Representative registered in any EU member state covers your legal obligations across all 27 EU member states. You do not need a separate AR in Germany, France, Italy, and so on — one AR agreement covers the entire European Union. NordMDR AB is registered in Stockholm, Sweden and provides EU-wide coverage under a single agreement.
Your EU AR handles several critical responsibilities:
Costs vary significantly by provider. Large global firms charge €200–300 per hour with annual retainer fees of €5,000–15,000. NordMDR AB offers transparent flat-fee pricing starting from a few thousand euros per year for simple Class I device portfolios — making EU market access affordable for small and mid-size manufacturers. Contact us for a specific quote based on your device portfolio and situation.
Yes. Since Brexit, UK-based manufacturers are treated as non-EU manufacturers and must appoint an EU Authorized Representative to sell in the EU — exactly the same as a US or Japanese manufacturer. Conversely, EU manufacturers selling into the UK now need a UK Responsible Person (UKRP). NordMDR AB provides EU AR services for UK manufacturers entering the European market.
EU MDR classifies medical devices into four risk-based classes:
Yes — every medical device sold in the EU must have a Technical File (for Class I) or Design Dossier (for Class IIa and above). This document package must include: a full product description and intended purpose, applicable standards and their application, risk management documentation per ISO 14971, clinical evaluation, post-market surveillance plan, labelling and instructions for use, and the Declaration of Conformity. NordMDR AB prepares complete Technical Files for all device classes.
Timeline depends on your device class. For Class I devices with good existing documentation, EU AR appointment and technical file preparation typically takes 4–8 weeks. For Class IIa, add Notified Body review which can take 3–9 months. For Class IIb and III, full conformity assessment typically takes 9–18 months. Starting early is critical — do not wait until you have a customer waiting for your product in Europe.
The Declaration of Conformity (DoC) is a legal document in which you as the manufacturer declare that your product meets all applicable EU requirements. It must include: the manufacturer's name and address, the EU AR's name and address, product description and identifiers, the EU MDR regulation reference, applicable standards, your signature and date. The DoC must be kept on file for 10 years and made available to Competent Authorities on request.
EUDAMED is the European Database on Medical Devices — the EU's centralised registry for all medical devices, manufacturers, importers, distributors, and authorised representatives operating in the European market. Every economic operator must register and obtain a unique SRN (Single Registration Number). EUDAMED is publicly accessible and Competent Authorities use it to verify compliance across all 27 member states.
EUDAMED full mandatory enforcement is coming in 2026–2027. After the enforcement date, any manufacturer, importer, distributor, or EU AR without a valid EUDAMED registration faces immediate market suspension. The registration process takes 4–8 weeks minimum, so starting now is strongly recommended to avoid missing the deadline.
No. Non-EU manufacturers cannot register in EUDAMED directly. You must first appoint an EU Authorized Representative, and your EU AR handles the EUDAMED registration on your behalf. Your AR registers as an Actor first (receiving their own SRN), then registers your company as a manufacturer, and then registers each of your devices — all linked together in the system.
Not exactly. CE marking is the visible mark on a product indicating it meets EU requirements. EU MDR compliance is the full regulatory process required for medical devices — of which CE marking is the end result. There are also other EU directives that require CE marking for non-medical products, such as the EMC Directive (2014/30/EU) for electronic products and the Low Voltage Directive (2014/35/EU) for electrical equipment.
Not automatically. For CE marking under the EU EMC Directive, your products must be tested to EU-harmonised standards (such as EN 55032, EN 61000 series). Test reports referencing only national standards from outside the EU are generally not accepted by EU Competent Authorities. Your test reports must explicitly reference the applicable EU harmonised standards. NordMDR AB can assess your existing test documentation and advise on what additional testing is required.
A pre-compliance assessment is a review of your product design and existing documentation against EU EMC requirements — conducted before committing to full laboratory testing. It identifies likely failure points and required standards early, when issues are cheap to fix. This typically saves 30–50% of total compliance costs compared to discovering problems during formal lab testing. NordMDR AB provides pre-compliance assessments for all product categories.
We can typically onboard new clients and have the EU AR agreement signed and in place within 5 business days of receiving your product information. EUDAMED registration follows shortly after. If you have an urgent deadline — for example a customer waiting for your product or an approaching compliance date — contact us and we will prioritise your case.
Yes. NordMDR AB operates on transparent flat-fee and project-based pricing — not hourly billing. Before any work begins you receive a clear written proposal with fixed costs and deliverables. There are no hidden fees or surprise invoices. Annual EU AR maintenance fees are fixed and agreed upfront.
NordMDR AB is registered in Stockholm, Sweden as a full EU legal entity. We cover all 27 EU member states under a single AR agreement: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
Contact us directly via our free compliance assessment form, read our EU AR guide, our EUDAMED guide, or our EMC compliance guide. We respond to all enquiries within 24 hours. If your question is a general one about EU MDR, CE marking, or EUDAMED, we are happy to answer it at no cost — no sales pitch, just genuine regulatory guidance.
Send us your specific compliance question. We respond within 24 hours with honest, practical guidance — completely free, no obligation.
Ask Your Question →