The European Association of Authorised Representatives (EAAR) represents Authorised Representatives (AR) based in various European Union (EU) Member States. Its members act on behalf of thousands of non-EU manufacturers of all sizes, covering millions of essential medical devices and in vitro diagnostics for EU patients. Its members are not part of the manufacturers’ corporate organisation and are fully independent from manufacturers.
EAAR has consistently contributed to strengthening the EU regulatory system, including as a stakeholder of the Medical Device Coordination Group. EAAR also cooperates with other medtech industry associations and recently co-signed the joint discussion paper “Future Governance of Medical Technologies in Europe” with other stakeholders such as MedTech Europe, AESGP, COCIR, FIDE and EUROM.
EAAR welcomes the opportunity to provide input on the revision of the MDR/IVDR, particularly regarding the role of the AR. We support the EU Commission’s initiative to simplify rules for medical devices and in vitro diagnostics, aiming “to ensure availability of safe and innovative devices to safeguard a high level of patient safety, public health and healthcare”.
EAAR would like to comment on several provisions of the Regulations that affect the role of the AR, or where the AR could play a role in making EU market access less burdensome for manufacturers while maintaining the Regulation’s overarching objectives related to patient safety, public health, and healthcare performance.
Digital label for AR and Importer
A position paper was published suggesting that the AR and Importer could be disclosed via a digital label. EAAR does not support the use of a digital-only information for the AR. Including the AR name and address directly on the device label ensures immediate visibility of essential contact information for users, distributors, and competent authorities, without dependence on electronic systems or internet access. Similar aspects may apply for the disclosure of the Importer(s).
Furthermore, the physical presence of the AR details on the device label supports legal clarity by identifying the EU entity required under MDR/IVDR Article 11 and MDR Annex I, Section 23.2 and IVDR Annex I, Section 20.2, allowing rapid compliance verification for vigilance or market surveillance purposes.
Moreover, having the AR details on the physical label strengthens traceability throughout the supply chain, providing a permanent reference unaffected by technological difficulties. Reliance solely on digital labelling could delay access to critical safety information and undermine practical enforcement of regulatory responsibilities.
If a manufacturer becomes insolvent and ceases business activities, digital labels will no longer be supported, and information about any AR or Importer(s) will no longer be available.
Device Registration
Article 11(3)(c) of the Regulations requires the AR to verify that the manufacturer has complied with its UDI and device registration obligations in EUDAMED, as set out in MDR Articles 27, 29 and IVDR Articles 24, 26. Currently the Regulations do not allow the AR to make device registrations on the manufacturer’s behalf (Article 11.4). This restriction is confirmed by MDCG 2022-16 paragraph 5b). Contrary to current requirements, however, EAAR supports allowing manufacturers the option to mandate their AR to create and update EUDAMED device registrations on their behalf.
Under the current system, it is practically possible for manufacturers to register and market devices without the AR having carried out the verification required by Article 11(3)(a) and (c). Allowing ARs to perform registration on behalf of the manufacturer would close this gap and ensure that ARs are aware of any significant post-market device modifications or changes to the range of devices covered by the mandate that have been introduced by the manufacturer.
Should the manufacturer continue to perform the registration, EAAR recommends that an additional step is included in EUDAMED to require the AR to indicate it has verified the device information provided by the manufacturer before the information becomes publicly available. This would ensure that data entered into the system accurately reflects the devices for which the AR is mandated.
Clarity for the verification requirements
It is apparent that there are different interpretations among Competent Authorities (CA) for what is meant by “verification” and “appropriate conformity assessment has been carried out” under Article 11(3)(a). MDCG 2022-16 paragraph 6 clarifies by interpreting these requirements as “(i.e. checks the existence of such documents) and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer. If the authorised representative considers or has reason to believe that the conformity assessment procedure is not appropriate for the device in question, they may inform the manufacturer.”
The Regulations and guidance therefore expect the AR to make a meaningful review of the manufacturer’s documentation to form an opinion on the selected conformity assessment procedure, with a view to advising the manufacturer if the AR has “reasons to believe that the conformity assessment procedure is not appropriate.” This would require at a minimum that the AR assess whether the device classification chosen by the manufacturer is consistent with the intended purpose. A clearer description of these expectations could be beneficial in the MDR/IVDR revision.
As mentioned under Point 1 above, there is currently no requirement in the Regulations for the manufacturer to advise the AR of any design changes or other device revisions after the initial AR verification. EAAR therefore considers that it would be helpful for the Regulations to address this communication gap between the manufacturer and AR.
Lastly, MDR Article 51(2) and IVDR Article 47(2) could be amended to allow disputes between the manufacturer and its AR, arising from the application of Annex VIII, to be referred to the CA of the Member State in which the AR resides or to any future EU-level governance structure established under the revised regulatory framework.
Vigilance reporting
When a vigilance case is registered in EUDAMED by the manufacturer, the Authorised Representative should automatically receive an immediate notification through the system. This is essential to enable the AR to promptly fulfil its Article 11 responsibilities, to respond without delay to competent authorities, and to avoid any risk of delayed safety actions.
Liability
The Regulations include product liability obligations which differ from those of Directive (EU) 2024/2853[4]. Because the AR is restricted by MDR/IVDR Article 11(4) from carrying out the majority of device compliance activities, under (EU) 2024/2853 it is highly unlikely that the AR would be held liable for defective products for which it had no responsibility for, among others, design, risk management and clinical evaluation.
EAAR proposes that MDR/IVDR Article 11(5) be deleted, as AR liability would be more appropriately and consistently governed through the horizontal requirements of Directive (EU) 2024/2853, which applies uniformly across economic operators and avoids duplicative frameworks.
EAAR (2025). EAAR signs joint paper on future governance of medical devices. Retrieved on 28/11/2025.
MDCG (2022). Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Retrieved on 28/11/2025.
Eur-Lex (2024). Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC. Retrieved on 28/11/2025.