New MDCG Guidance documents released (October 2022)

On October 31^st, 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This document provides guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)  (MDCG 2022-16). Also in October, a new revision of the Q&A on the requirements relating for notified bodies has been released (MDCG 2019-6 Rev4).

MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

This document intends to provide guidance on relevant requirements for Authorised Representatives (AR) under the MDR and IVDR. Below are some of the highlights of this guidance:

• Legal representative
  • This MDCG does not provide guidance on devices intended for clinical investigation (MDR) or devices for performance study (IVDR). This is as per this guidance, the legal representative is not defined as the
• Designation and mandate
  • It clarifies that even for ‘internal’ AR, “a mandate should be drawn up irrespective of whether the AR is independent/outside of, or is part of the same larger organization as the manufacturer.”
  • There are some words on how the importer should verify that the manufacturer has designated the AR
• Obligation of the Authorised Representative
  • It includes some useful language on obligations of the AR
    • It is expected that the AR actively checks that the conformity assessment procedure for devices in scope of the mandate is appropriate for the device is question
    • If further specifies what documentation the AR must be able to produce in order to meet the requirements in article 11(3) (d) of MDR/IVDR to “provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device”.
    • It clarifies the manufacturer’s obligation to ensure the authorised representative has the necessary documentation ‘permanently available’ in order to fulfil the tasks specified in Article 11(3) of the MDR/IVDR
    • It reiterates that manufacturers may delegate certain activities to the AR and also which responsibilities may not be delegated
    • The AR is also required to verify that the manufacturer has complied with its UDI and devices registration obligations in EUDAMED
• Liability
  • Article 11(5) of the MDR/ IVDR imposes joint liability between manufacturers and ARs for defective devices. This guidance advises that this is conditional upon the manufacturers failure to comply with it’s obligations. Therefore, this guidance advises that the AR verifies that the manufacturer has sufficient measures in place for financial coverage for defective products (e.g., product liability insurance).
• Termination
  • Given that under Article 11(2) of the MDR/ IVDR the mandate is ‘effective at least for all devices of the same generic device group’ of a manufacturer, 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 authorised representative), the out-going authorised 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 the AR
  • Per Article 12 of the MDR/ IVDR, in general, a tripartite agreement should exist under Article 12 of the Regulations, except in cases where this is ‘not practicable’ i.e. in particular where the outgoing authorised representative ceases to exist (for example, due to bankruptcy), they are no longer traceable or, where justified, for other substantial reasons making the conclusion of an arrangement between the parties not possible
• Person responsible for Regulatory Compliance (PRRC)
  • ARs are required to have permanently and continuously at their disposal at least one Person Responsible for Regulatory Compliance (PRRC) who possesses the requisites as per article 15(6) of the MDR/ IVDR.
  • If the mandate with the manufacturers also covers ‘legacy devices’, those are not required to have a PRRC.
• 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 ‘legacy devices’. Therefore, the ARs and manufacturers should update their Mandate accordingly for such legacy devices.