The Medical Device Coordination Group (MDCG) released a guidance document on Authorized Representatives (MDCG 2022-16): HERE
Below are some of the highlights from the guidance.
Representative for Clinical Studies
MDCG 2022-16 does not include requirements for clinical investigation representatives. This is because, per the MDR/IVDR, the legal representative for a clinical investigation is not defined as an authorized representative.
Responsibilities between the Manufacturer and Authorized Representative
The MDCG guidance document reiterates that manufacturers may delegate certain activities to the Authorized Representative. Examples include:
- Requirement for a system for recording and reporting incidents and field safety corrective actions.
- Ensure the technical documentation, EU Declaration of Conformity and if applicable, a copy of any certificates, is maintained and available to Competent Authorities for a period of at least 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market (or 15 years for implantable devices).
- Upon request, provide the Competent Authority with the information and documentation necessary to demonstrate the conformity of the device, including provision of samples.
Any delegated items must be noted in the Mandate between the manufacturer and the authorized representative.
The MDCG guidance also reiterates which responsibilities may not be delegated to the Authorized Representative. Examples include:
- Ensure that the design and manufacturer of the device is in accordance with the requirements of the Regulation.
- The requirement to establish, document, implement and maintain a system for risk management.
- Drawing up of the Declaration of Conformity.
- Ensuring that the device labeling and instructions for use is compliant with the Regulation and that the European translation requirements have been met.
- Meet UDI requirements.
While manufacturers may not delegate certain activities to their Authorized Representative, there is nothing that prohibits the Authorized Representative from supporting the manufacturer in these tasks, if both parties agree to do so.
For more information on the role, please read: European Authorized Representative
Reiterates that the Authorized Representative is required to verify that the manufacturer has complied with its UDI and devices registration obligations in EUDAMED.
NOTE: EUDAMED is currently delayed. For more information, please read: New EUDAMED ‘Go Live’ Date is Q2 2024
Access to Device Technical Documentation
Per Article 11(3) of the MDR and IVDR, the Authorized Representative must verify that the EU Declaration of Conformity and technical documentation have been drawn up. As well, that the manufacturer has applied the correct conformity assessment procedure to the device.
The Authorized Representative must also keep a copy of the technical documentation, the EU Declaration of Conformity and, if applicable, a copy of the relevant certificate (including any amendments and supplements of such a certificate), issued in accordance with Article 56 MDR or Article 51 IVDR.
This includes a period of at least 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market, and in the case of implantable devices, a period of at least 15 years after the last device has been placed on the market.
If the Authorized Representative is inspected by the Competent Authority, they must be able to show that they have reviewed the device documentation.
The manufacturer’s obligation, as outlined in Article 10 of the MDR/IVDR, is to ensure the Authorized Representative has the necessary documentation ‘permanently available’ to them. The MDCG guidance states:
“In practical terms having ‘permanent access’ to such documents, should imply constant availability via electronic or physical storage, either shared or otherwise.”
The MDR/IVDR imposes potential joint liability between manufacturers and Authorized Representatives for defective products.
The MDCG guidance document advises that the Authorized Representative’s liability is conditional upon the manufacturer’s failure to comply with its obligations and can therefore only be liable in cases where:
- First, the manufacturer’s liability for a defective device is established under applicable Union or national law, e.g. under the product liability Directive 85/374/EEC as transposed into national law which establishes “strict liability” for defective products; and
- Second, it is established that the manufacturer has not complied with its obligations under Article 10 MDR/IVDR.
The MDCG guidance, therefore, advises that Authorized Representatives may wish to verify that the manufacturer has sufficient measures in place for financial coverage for defective products (e.g., product liability insurance).
Article 11(2) of the MDR/IVDR states that the Authorized Representative mandate is ‘effective at least for all devices of the same generic device group’ of a manufacturer. Therefore, the termination of the mandate is only possible with respect to the whole generic device group and not a specific device within that group, unless the specific device is removed/withdrawn from the market and so is outside the scope of the effective mandate.
Further, in the event of a problematic termination (e.g. where the manufacturer fails or refuses to address a non-compliance identified, or is either not responsive to or traceable by the Authorized Representative), the out-going Authorized Representative is also advised to inform the Competent Authorities and where applicable, the Notified Body, of the extent of the manufacturer’s non-compliance.
Change of Authorized Representatives
In general, a tripartite agreement should exist between the out-going Authorized Representative, the in-coming Authorized Representative, and the Manufacturer. This is per Article 12 of the MDR/IVDR.
Exceptions may be granted where this is ‘not practicable’, such as where the out-going Authorized Representative goes out of business and is no longer traceable.
However, even if it is not possible to put a tripartite agreement with the out-going Authorized Representative, they are still obligated, per Article 12(d), to forward complaints to the Manufacturer or incoming Authorized Representative.
Person Responsible for Regulatory Compliance (PRRC)
Authorized Representatives are required to permanently and continuously have at least one Person Responsible for Regulatory Compliance (PRRC) at their disposal.
The MDCG notes that Authorized Representatives are not required to appoint a PRRC for MDD/AIMDD/IVDD CE marked (“legacy”) devices.
Further, it reiterates the information from MDCG guidance 2019-7, which is that the PRRC for an Authorized Representative and a non-EU manufacturer may not be the same person. i.e., Authorized Representatives may not act as a PRRC for its clients.
Market Surveillance, Post-Market Surveillance, Vigilance and Registration
The guidance document notes that the MDR/IVDR requirements around market surveillance, post-market surveillance, vigilance and registration of economic operators and devices apply for all devices. This includes MDR/IVDR CE Marked devices, as well as MDD/AIMDD/IVDD transitional devices (“legacy devices”).
Therefore, Authorized Representatives and Manufacturers should update their Mandate accordingly for any such legacy devices.