Last September 2025, the European Medical Device Coordination Group took a firm step toward greater regulatory clarity with the publication of the 4th edition of the Manual on the Delimitation and Classification of Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). This document will serve as an essential consensus guide for manufacturers of medical and in vitro diagnostic devices worldwide who seek to market their products in the demanding European Union (EU) market.
This update is particularly important because it helps define whether a product falls under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR). However, it keeps unchanged and mandatory the designation of a European Authorized Representative or EC REP for manufacturers not established in the EU.
What Is New In This Fourth Edition Of The Manual?
Although the core of the regulation (MDR/IVDR) remains unchanged, as mentioned, the new edition offers more detailed interpretation and concrete examples on the delimitation and classification of products, thereby reducing the possibility that incorrectly classified products enter the European market.
In this sense, the 4th edition of the Manual includes:
- Clarification in Software Classification: One of the fastest-growing and most complex areas is Software as a Medical Device (SaMD). The 4th edition manual adds more case studies to clearly differentiate general wellness applications (not regulated) from those intended for diagnosis, monitoring or treatment, which are strictly regulated.
- Combined and Aesthetic Products: New notes have also been included on aesthetic products with potential physiological impact (such as certain dermal fillers), and the criteria have been refined to decide when a drug–medical device combination should primarily be governed by medicinal product legislation or by medical device regulation.
- Consistency and Real Case Scenarios: The update reflects the experience of notified bodies and competent authorities, providing greater predictability for manufacturers. Practical examples of products that have been subject to “borderline cases” are included, such as dental irrigation solutions or nasal sprays with antibodies.
In essence, it reduces uncertainty for manufacturers by offering a much clearer roadmap for the classification of innovative products, which translates into a potentially more agile commercialization process for any company interested in entering the European market.
The Indispensable Mandate: The European Authorized Representative
For any manufacturer of medical devices or IVDs not established in the EU, it remains legally mandatory to have a European Authorized Representative in order to place products on the European market. This is more than a simple requirement: it is a regulatory bridge and a safety guarantee for European patients.
The EC REP is the legal link between a manufacturer outside the EU and European health authorities. It performs vital functions for regulatory compliance:
- Official Point of Contact: Acts as the main interlocutor for the competent national authorities of EU Member States, especially in matters of market surveillance or inspections.
- Custodian of Technical Documentation: Must keep the Technical Documentation (the “Technical File” or Design Dossier) and the EU Declaration of Conformity available at all times for inspection by competent authorities.
- Registration in EUDAMED: Is responsible for ensuring that the manufacturer meets its obligations to register devices in the European EUDAMED database.
- Post-market Cooperation (Vigilance): Must actively cooperate with authorities in any necessary preventive or corrective action. This includes immediate communication to the manufacturer regarding complaints, adverse incidents or Field Safety Corrective Actions (FSCA).
- Verification and Labelling: Must also verify that the EU Declaration of Conformity and technical documentation have been drawn up and that the product correctly bears the CE marking, as well as that its own name and address appear on the label, packaging or accompanying documentation.
Why Is It Mandatory To Have An EC REP?
The obligation to designate an EC REP for manufacturers outside the EU is established in Article 11 of the Medical Device Regulation (MDR) and Article 11 of the In Vitro Diagnostic Regulation (IVDR).
The reason behind this obligation is simple but powerful: to guarantee safety and market surveillance in the European market.
By requiring a legally established entity within the EU, authorities ensure that, in the event of a safety issue or adverse incident, there is always a known and accessible point of contact within European territory to take immediate action.
It also ensures that products manufactured outside Europe are supervised under the same high standards as those produced within the bloc, thus maintaining the integrity of the healthcare system and patient trust.
Therefore, without a valid EC REP, no external manufacturer can obtain CE marking for its medical devices and, consequently, cannot legally market its devices in the EU. In other words, it is the regulatory cost of entry.
Strategies For Choosing The Right EC REP
Choosing a European Authorized Representative is a strategic and critical decision that directly influences the success and speed of entry of any medical device or in vitro diagnostic device into the European market. Therefore, it is not a task to be taken lightly.
Here are some essential criteria to consider when choosing an EC REP partner:
- Experience and specialization.
- Always look for a company with a proven track record and deep knowledge of MDR and IVDR. Your EC REP should be well acquainted with the latest guidance, such as the 4th edition of the Classification Manual from September 2025.
- Make sure they have specific experience with your particular type of device. For example, if your product is for In Vitro Diagnostics, the EC REP you hire should have strong experience in this field.
Strength and Qualifications
- The Regulation requires that the EC REP, like the manufacturer, permanently have a Person Responsible for Regulatory Compliance (PRRC) available. Ask who the PRRC is and what their qualifications are.
- Preferably, choose an EC REP with a certified Quality Management System (QMS), for example under ISO 13485, which demonstrates their commitment to the highest standards.
Communication and Support
- You will need a partner that offers smooth, multilingual communication and the ability to respond quickly to authority inquiries.
- Ask how they manage information exchange and adverse incidents. Remember that speed in these situations is vital.
Mandate Clauses
- The written mandate signed by both parties is a fundamental document. Review it carefully to ensure that responsibilities are clearly defined and that obligations inherently belonging to you as the manufacturer are not being delegated to the EC REP.
An Ally In Spain: CMC Medical Devices & Drugs SL
In Spain, there is a well-recognized company called CMC Medical Devices & Drugs SL, which is a member of the European Association of Authorized Representatives (E.A.A.R) and has a qualified professional regulatory team to act as an authorized representative for manufacturers outside the EU.
Since 2014, they have provided representation and consultancy services to hundreds of manufacturers seeking to enter the EU market. In addition, they are actively involved in the European Commission Working Groups and in Horizon Europe, the EU’s research and innovation program.
Furthermore, CMC maintains close communication and cooperation with the authorities of the bloc and can carry out the corresponding procedures for manufacturers in accordance with official instructions.
As you can see, choosing the right EC REP is not just a matter of meeting a requirement, but of ensuring effective collaboration that allows your company to focus on innovation and growth, while an expert in Europe handles regulatory management on the ground.
