Spotlight

EU Authorized Representative Verification Process

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What is the extent of the AR’s verification process?

The AR is obliged to verify certain aspects of your compliance with the EU Regulations. The major part of this involves the verification of your technical documentation which must have been drawn up in accordance with Annex II and III of the Regulations. The extent of the verification will differ from one AR to the other, with some taking a deeper dive than others into the compliance of your documentation.

However, it is agreed that the verification process should go further than just ensuring that documents with the correct headings have been provided, and thus a review of the content will always take place. This review may deepen with higher-risk devices.

As part of this review, the AR must also verify that the route of conformity for the devices it represents is correct. This is critical in ensuring that all devices making their way to the EU market have passed through the appropriate regulatory pathway.

In reviewing the manufacturer’s documentation, the AR should be clear on any deficiencies and should guide the manufacturer to close any gaps. The AR may also be able to provide consulting services to amend this documentation; however, the manufacturer remains responsible for such documentation.

Documentation Access and Retention

The manufacturer must ensure that the AR has continuous and permanent access to the following:

  • Declaration of Conformity.
  • Technical Documentation.
  • Notified Body Certificates, including amendments and supplements.

In addition to these, the Regulations require that ARs also hold the following documentation and information under certain conformity assessment procedures:

  • Quality Management System (QMS) procedures and specific records demonstrating regulatory compliance.
  • Information on significant changes made to the QMS or device.
  • Notified Body decisions and reports.

The making available of this information is typically achieved through a shared folder which shall be kept up to date with any new or amended documentation.

Vigilance

The EU Authorised Representative’s involvement in medical device vigilance is one of their key roles. They shall ensure to forward to the manufacturer any reports or complaints relating to the devices they are designated to represent.

Although not required to by the Regulations, the AR’s mandate may include an obligation to handle vigilance on the manufacturer’s behalf. In these situations, the AR must ensure that they meet the respective vigilance reporting timelines and MDR requirements.

Otherwise, the AR’s role in vigilance is mostly that of a middleman between the Competent Authority and the manufacturer, relaying information between the two. Nevertheless, you would want to appoint an AR who is able to guide you in meeting your own reporting obligations or who could be subcontracted to do so.

Registration

With respect to the AR’s obligations for registration, they are required to register as an EU Authorised Representative on Eudamed and obtain their Single Registration Number (SRN). They shall ensure that these details are correct and any changes in the details inputted should be immediately amended on Eudamed.

The AR must ensure that the manufacturer has met similar obligations for registering on Eudamed and must verify that they have registered their devices and applied a Unique Device Identifier. This obligation cannot be delegated, however, EU ARs are able to submit registrations on behalf of the manufacturer.

Although Eudamed has not been fully implemented, we encourage all economic operators to register for their SRN and manufacturers to register their devices on Eudamed. Otherwise, they must meet the registration requirements as found locally to their AR until Eudamed is fully implemented.

Liability

Given the pivotal role the AR has in ensuring medical device compliance, regulators considered it appropriate to make the AR legally liable for defective devices in the event that a manufacturer established outside the EU has not complied with their general obligations. As such, the AR is “jointly and severally liable” with the importer and the manufacturer without prejudice to the provisions of Directive 85/374/EEC (liability of defective products).

This means that the AR joins the chain of liability and a claim can be made against them. Although the Regulations do not require the AR to acquire insurance, many are obtaining insurance policies for appropriate coverage and are also requesting that the manufacturer indicates the AR specifically within their own policy.

Further guidance on the EU Authorised Representative can be found in MDCG 2022-16.