MDCG 2022-16: Guidance on EC-REP

The MDCG has released an important guidance document which specifically tackles the obligations of the EU Authorised Representative (AR). It intends to provide clarity on the extent of the AR’s responsibilities to all stakeholders in the EU.

For some time, EU AR’s have struggled to come to a consensus on the extent of their obligations related to the verification of information or documentation provided by the manufacturer. MDCG 2022-16 sheds some light on this in that the AR is only required to ensure that technical documentation has been drawn up i.e. the AR is not expected to verify that the documents are correct. This may not stop some EU Authorised Representatives from going the extra mile, after all, they may be held liable for product defects which may trace back to negligent checks on their side.

Speaking of liability, the guidance confirms that ARs may be held liable for product defects. It is in the AR’s interests to ensure that the legal manufacturer has met all their obligations. Also, it is good practice to request the manufacturer to provide evidence of Product Liability insurance or sufficient financial cover. Furthermore, the AR may wish to obtain insurance for their activities.

MDCG 2022-16 also confirms that “permanent access” to the manufacturer’s documentation implies “constant availability via electronic or physical storage, either shared or otherwise”. Therefore, manufacturers and ARs shall ensure that the most current documentation is in the AR’s possession, or the AR has the ability to access the latest versions. This arrangement could take the form of a shared cloud folder or the manufacturer putting together a procedure whereby all new documents are sent to the AR.

With respect to manufacturers of only legacy devices, the AR’s obligations under the MDR shall only be limited to those MDR requirements applicable to legacy products. For device manufacturers in general, this MDCG document should help clarify the extent to which your EU Authorised Representative needs to review your documentation. It should empower you to question why certain decisions are made with respect to your documentation.

MDCG 2022-16