Most non-EU manufacturers preparing for CE marking focus heavily on clinical evidence and regulatory documentation. While these are undeniably critical, the EU MDR introduces a range of operational and market entry requirements that are frequently underestimated and can block or significantly delay market access.
In this blog, we highlight the operational factors that are often overlooked but critical for successful EU market entry.
Economic Operators: Roles You Cannot Ignore
The MDR defines clear responsibilities for all economic operators: the legal manufacturer (Article 10), the Authorised Representative (Article 11), importers (Article 13), and distributors (Article 14). All legal manufacturers, ARs, and importers must be registered in EUDAMED and obtain a Single Registration Number (SRN).
For non-EU manufacturers, appointing an EU Authorised Representative (AR) is mandatory. The AR must validate registration, ensure that contractual, technical, and vigilance responsibilities are clearly defined, and act as a visible contact for Competent Authorities.
Every legal manufacturer must also assign a Person Responsible for Regulatory Compliance (PRRC) who meets the qualifications defined in Article 15.
It is important to note that actor registration as a legal manufacturer and having a PRRC in place are mandatory before any submission of technical documentation to a Notified Body, as both must be referenced within it.
When a non-EU legal manufacturer intends to conduct a clinical investigation in the EU, a legal representative must also be appointed to submit the application to the Competent Authority.
EUDAMED and UDI: More Complex Than You Think
EUDAMED is the EU's central transparency and tracking system for medical devices. The actor registration and certificates modules are already mandatory. The UDI/device registration module becomes mandatory (from a regulatory standpoint) in May 2026. The market surveillance module is not yet available.
Non-EU manufacturers must register via their AR, and this process requires a formal mandate for the AR to verify and submit the application to the relevant Competent Authority.
The EU's UDI system differs from U.S. and Chinese systems in important ways. The MDR introduced the Basic UDI-DI concept, which allows grouping of devices that share the same intended purpose, risk class, essential design, and manufacturing characteristics. This concept does not exist in the U.S. GUDID or China's UDID systems.
UDI implementation requires:
- Assignment of UDI-DI and Basic UDI-DI
- Placement of UDI carriers on the device or packaging
- Registration in the EUDAMED Device/UDI module
These obligations are already mandatory, except for direct marking of Class I reusable devices, which becomes required from 26 May 2027.
Language Requirements: Plan Early
European countries operate in multiple languages, resulting in strict requirements for Instructions for Use (IFU) and labelling.
Validated translations into the official language(s) of each target Member State are mandatory. Language compliance directly impacts timelines, costs, packaging design, and IFU size.
These aspects are often underestimated or addressed too late, leading to avoidable delays.
Looking to Go Deeper?
Operational readiness is often underestimated, yet it plays a critical role in determining whether EU market entry progresses smoothly or becomes delayed.
Download the QbD Group whitepaper “Home Market Approval ≠ EU Readiness” to explore the full scope of operational, regulatory, and clinical gaps.
关于作者
PhD Physics, MSc Medical Physics · Business Unit Manager RA MD
Anne-Sophie is a Regulatory Affairs leader with over two decades of experience in medical physics, diagnostic imaging, and medical device regulation. She supports clients navigating EU MDR, FDA, and international regulatory frameworks.
关于作者
Business Unit Manager Medical Affairs
12 years of experience in the medical device field. Expert in clinical evidence and medical writing for Class I to Class III devices, including MDSW and AI-driven MDSW, as well as safety management in clinical investigations.
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