In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations and responsibilities of the Authorised Representative. According to the Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR), when the manufacturer is not established in the EU, they must appoint a European Authorised Representative (EAR).
Specifically, the new MDCG Guidance addresses several points:
- Definitions
- Designation, mandate, termination of the mandate
- Registration and verification obligations
- Minimum tasks and responsibilities
- Liability
- Change of EAR
- Person Responsible for Regulatory Compliance (PRRC)
- Market Surveillance
- Transitional provisions
Please find below an overview on selected aspects included in the Guidance:
Designation, mandate, termination of the mandate
For one specific generic device group, the manufacturer should designate only one authorised representative (i.e. a ‘sole’ authorised representative’). The manufacturer and the authorised representative can freely structure the contractual relationship as long as there is a written mandate. Especially, the mandate must meet the minimum requirements of Article 11 (3). However, the mandate can also include additional tasks agreed between the parties. Nonetheless, the MDCG clarifies that the mandate must not delegate some of manufacturer’s obligations to the authorised representative as per Article 11(4), but the authorised representative can assist in the performance of those tasks.
There must be a written mandate between the EAR and the manufacturer even if the EAR is part of the same organization as the manufacturer.
When the manufacturer does not respect their obligations, the mandate should authorise the EAR to terminate the mandate. The termination of the mandate is only possible for the whole generic device group and not for a specific device. The termination of the mandate for one specific device is possible just upon removal or withdrawal from the market of that specific device. Additionally, the EAR must inform the national competent authorities and the notified body about the termination. Particularly, the out-going authorised representative is also advised to inform the mentioned parties – in case of problematic terminations – about the extent of the manufacturer’s non-compliance.
Registration and verification obligations
In addition to the EUDAMED registration, the authorised representative must:
- Check and update registered information (any update to perform within one week).
- Verify the accuracy of the data not later than one year after the initial submission of the information, and every second year thereafter.
Toward the manufacturer, the EAR must verify that the manufacturer has complied with the UDI and devices registration obligations.
Minimum tasks and responsibilities
Article 11 (3) of the Regulations defines the minimum tasks and responsibilities of the EAR. In addition to the documentation verification tasks, the EAR must address any request of the competent authority to demonstrate the conformity of a device. Moreover, the EAR must also inform the manufacturer of each request by competent authorities, cooperate with them, and take preventive or corrective actions.
Among other things, the authorised representative should also be able to prove that they performed the verification tasks.
Liability of EAR
According to article 11 (5), the EAR is legally liable for defective devices together with the manufacturer. However, the liability of the EAR is limited to the following circumstances -when it is established:
- The manufacturer’s liability for a defective device under applicable Union or national law, e.g. under the Product Liability Directive as transposed into national law which establishes “strict liability” for defective products.
- The manufacturer has not complied with its obligations.
Thus, the authorised representative has a particular interest to make sure that the manufacturer has fulfilled their obligations, especially those regarding the liability insurance.
Change of EAR
For a change of authorised representative, typically there should be a tripartite agreement between the previous EAR, the new EAR, and the manufacturer. In certain cases, a tripartite agreement is not applicable. For instance, if the authorised representative no longer exists or is untraceable. Consequently, when it is not possible to involve the outgoing authorised representative, the obligation under Article 12 (d) should apply.
Person Responsible for Regulatory Compliance (PRRC)
Article 15 (6) of the Regulations states that the EAR must have permanently and continuously at their disposal at least one Person Responsible for Regulatory Compliance (PRRC). However, when the mandate covers “legacy devices”, this obligation does not apply.
MDCG Guidance on PRRC provides further insight on the Person Responsible for Regulatory Compliance.
Market surveillance
Article 11 (3) of the Regulations defines the responsibilities of the EAR. Notably, competent authorities can consult the authorised representative regarding market surveillance measures. Furthermore, the EAR must make the documentation available to competent authorities. Indeed, the authorised representative is subject to announced and unannounced inspections of competent authorities.
Transition Provisions
In regards to transition provisions, the requirements of the previous Directives as well as legacy requirements of the new Regulations apply. Specifically, this refers to the requirements concerning market surveillance, post-market surveillance, vigilance, and registration of
economic operators and devices.
Check our Library of Documents for many other Guidance documents!
Leave a Reply