EU REP vs EC REP Symbol: Why the Old Symbol Signals Outdated Documentation

The transition from the Medical Device Directives (MDD and AIMDD) to the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR, Regulation (EU) 2017/746) has brought significant changes. One such change, often overlooked, pertains to the symbol identifying the authorised representative. Understanding the correct symbology is crucial for all economic operators within the medical device supply chain. This document explains the evolution and current requirements for the authorised representative symbol.

#The Role of the Authorised Representative

For devices manufactured outside the European Union, an authorised representative (AR) is legally mandated to act on behalf of the manufacturer. This role is fundamental to ensuring compliance with EU legislation. Under the MDR and IVDR, the authorised representative performs specific tasks detailed in Article 11 MDR and Article 10 IVDR, respectively. These tasks include verifying the Declaration of Conformity and technical documentation, providing authorities with necessary information, and registering in EUDAMED.

#Designation of the Authorised Representative

Manufacturers not established in a Member State must, by written mandate, designate a single authorised representative. This designation must clearly define the tasks the AR is expected to perform. Article 11(3) MDR and Article 10(3) IVDR require that the AR’s name, registered trade name or registered trade mark, and address be indicated on the device, its packaging, or its accompanying documentation. This is where the specific symbol becomes relevant.

#Evolution of the Authorised Representative Symbol

Under the previous Medical Device Directives (93/42/EEC, 90/385/EEC, 98/79/EC), the authorised representative was commonly identified by the symbol ‘EC REP’. This symbol was widely recognised and used on device labelling across the EU. The symbol was standardised by EN 980:2008 and later superseded by EN ISO 15223-1:2016.

With the entry into force of the MDR and IVDR, the terminology and associated symbology have evolved. The Regulations refer to an 'authorised representative' without explicit reference to 'EC' in their text. However, harmonised standards provide the visual representation.

#Current Harmonised Standard and the 'EU REP' Symbol

The current harmonised standard for symbols to be used with medical device labels, labelling and information to be supplied is EN ISO 15223-1:2021, 'Medical devices, Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements'. This standard introduces the 'EU REP' symbol, replacing the 'EC REP' symbol. Specifically, ISO 15223-1:2021, Symbol 5.1.2, designates the 'EU REP' symbol as the identifier for the 'authorised representative in the European Union'.

This change reflects the modern regulatory framework, encompassing all EU Member States and reflecting a broader scope of European economic cooperation beyond just the European Community. The use of 'EU REP' is thus the current and correct symbol for devices placed on the EU market under the MDR and IVDR.

#Implications of Using the Incorrect Symbol

Using the 'EC REP' symbol instead of the 'EU REP' symbol has several implications:

• Non-conformity with Labelling Requirements: Article 10(4) MDR and Article 9(4) IVDR stipulate that manufacturers shall ensure that devices are accompanied by the information required pursuant to Section 23 of Annex I MDR and Section 20 of Annex I IVDR, respectively. Annex I, Section 23.2(h) MDR and Annex I, Section 20.2(h) IVDR specifically require the name, registered trade name or registered trade mark, and address of the authorised representative to be indicated. While the Regulations do not explicitly specify the symbol, reliance on harmonised standards like ISO 15223-1:2021 is presumed for specific visual representation. Non-compliance with harmonised standards, when used for presumption of conformity, can lead to questions regarding the overall conformity of the device.

• Outdated Documentation and Processes: The presence of the 'EC REP' symbol strongly suggests that the device's labelling, and potentially its entire technical documentation, has not been updated to align with the MDR or IVDR requirements. This could indicate broader issues with the manufacturer's Quality Management System (QMS) and its transition strategy.

• Market Surveillance Scrutiny: National competent authorities conducting market surveillance may identify the incorrect symbol as a potential non-conformity. This could trigger further investigations into the device's compliance, potentially leading to corrective actions, withdrawal from the market, or other enforcement measures as per Article 93 MDR or Article 88 IVDR.

• Reputational Risk: For distributors and importers, placing devices on the market with outdated or incorrect labelling symbols can damage their reputation and signal a lack of due diligence in verifying device conformity.

#Requirements for Economic Operators

Economic operators have specific responsibilities regarding device labelling and the authorised representative:

#Manufacturer Responsibilities

Manufacturers established outside the EU are primarily responsible for ensuring that their devices bear the correct 'EU REP' symbol and that their authorised representative is designated and correctly identified. This includes updating all relevant labels, packaging, and instructions for use.

#Importer Responsibilities

Importers must ensure that the device bears the CE marking and is accompanied by the information required pursuant to Article 13(2) MDR and Article 12(2) IVDR. This includes verifying that the manufacturer has designated an authorised representative and that the correct symbol, 'EU REP', is used. If an importer considers or has reason to believe that a device is not in conformity with the MDR or IVDR, they shall not place the device on the market until it has been brought into conformity.

#Distributor Responsibilities

Distributors must act with due care in relation to the requirements applicable to them. Before making a device available on the market, distributors shall verify that the device bears the CE marking, that the EU declaration of conformity has been drawn up, and that the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 14(2) MDR and Article 13(2) IVDR. This implicitly includes checking for the correct authorised representative symbol.

#Table: Symbol Comparison and Legal Basis

#Common mistakes in practice

• Failure to update existing device labels: Devices manufactured and placed on the market after the MDR/IVDR Date of Application (26 May 2021 for MDR, 26 May 2022 for IVDR) must bear the 'EU REP' symbol. Legacy devices placed on the market under the Directives may still bear the 'EC REP' symbol, but this status needs careful management and verification against transition periods.
• Incorrectly applying the new symbol to legacy devices: While new devices require 'EU REP', updating the label of a legacy device (placed on the market under the Directives) to 'EU REP' without a full conformity assessment against the MDR/IVDR can be misleading and imply MDR/IVDR compliance which may not exist.
• Inadequate verification by importers and distributors: Importers and distributors failing to check the authorised representative symbol as part of their Article 13 MDR or Article 12 IVDR obligations.
• Printing errors or illegible symbols: Any symbol, including 'EU REP', must be clearly legible and conform to the specifications of ISO 15223-1:2021.
• Using a non-standard symbol: Inventing a new symbol or using text instead of the prescribed harmonised symbol can lead to non-conformity.

#The Role of EUDAMED

EUDAMED, the European Databank on Medical Devices, serves as a central repository for information concerning medical devices and economic operators. Authorised representatives are required to register in EUDAMED as per Article 31 MDR and Article 28 IVDR. This registration will link them directly to the manufacturers they represent and the devices they act for. The public and market surveillance authorities can then verify the authorised representative's details against the information on the device label and in EUDAMED. While EUDAMED does not directly enforce the symbol's visual presentation, it ensures that the designated authorised representative is officially registered and verifiable. Readers should confirm the current status and scope of EUDAMED modules with their national competent authority, as the full functionality is being rolled out in stages. Utilising platforms that integrate with EUDAMED can assist in managing compliance requirements related to authorised representatives, for instance, by offering robust data management for registered economic operators. Find out more about EUDAMED data management at https://eudamedai.com/#funkcije.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.