With the new MDR’s coming closer it becomes urgent for companies present on the EU market to sort all matter of distribution issues. The EU distinguishes several levels of Economic Operators: Manufacturer, Authorized Representative (AR), Importer and Distributor. In this first article we will review the role of the Authorized Representative.
The Authorized Representative
Any foreign Manufacturer who does not have a physical presence in the EU must appoint an Authorized Representative for as long as the Manufacturer sells devices in the EU.
An Authorized Representative is any natural or legal person established within the EU who has received and accepted a written mandate from you, the Manufacturer, to act on your behalf in relation to specified tasks with regards to the Manufacturer’s obligations.
The Authorized Representative Under the MDD, IVDD, AIMDD
The Directives (MDD, IVDD, AIMDD) do not include a detailed description of the roles and responsibilities of the Authorized Representative. But, a few responsibilities are clear:
- The AR will register with the Competent Authority of the Member State where they have their registered place of business.
- The Manufacturer or the AR must notify the Competent Authorities of the Member States in which the Manufacturer intends to conduct a clinical investigation but may delegate the task entirely or in part to the AR.
- The Manufacturer may instruct the AR to initiate certain procedures under the MDD, IVDD and AIMDD. A contract between the Manufacturer and the AR must explicitly address this delegation of performance. Under the MDD for instance, a Manufacturer may instruct their AR to initiate procedures described in Annex III, IV, VII and VIII of the MDD.
- The AR will be contacted by the Competent Authority or other EU bodies regarding the Manufacturer’s obligations under the Directives regarding such matters as:
Making available declarations of conformity, technical documentation, information related to market surveillance etc. the information may reside with the AR or with the Manufacturer, provided the Manufacturer makes it available to the AR in a timely fashion.
When a Member State finds a device should be withdrawn, prohibited or restricted from being placed on the market. Or when a Member State carried out an assessment after an incident, as well as several other instances. In these situations, the AR is responsible for communications with the Manufacturer.
The above listed responsibilities are but a sampling. For a full list refer to the MDD, AIMDD and IVDD. The MEDDEV published a Guideline for Authorized Representatives. The Guideline is not legally binding.
The Authorized Representative Under the MDR, IVDR
- The AR must verify that the EU declaration of conformity and the technical documentation have been drawn up, and where applicable a proper conformity assessment has been carried out.
- The AR must keep available a copy of the technical documentation and needs to provide that information to the Competent Authority, in a Union Member language determined by the Member State, when asked to demonstrate conformity of the device. This requirement may lead the Manufacturer to more carefully review the technical documentation.
- Besides, the MDR’s require that the AR sever the relationship if they find that the Manufacturer, do not comply with the MDR’s obligations. In such a situation the AR will also need to inform the Competent Authority -and where applicable, the Notified Body involved in the conformity assessment -of the termination and the reason for such.
- AR’s must immediately inform the Manufacturer of complaints, reports from healthcare professionals patients and users about suspected incidents, effectively recruiting the Authorized Representative into market surveillance.
- The AR will also need have at their disposal, permanently and continuously at least one person responsible for compliance with the MDR.
- Furthermore, the AR will be jointly and separately held responsible for any mishaps.
Finally, the MDR requires that the Manufacturer who wants to change Authorized Representatives spells out the modalities of such a change – where practicable – with the outgoing and the incoming Authorized Representative in a 3-way agreement.
The resulting effect of the MDR/IVDR on your Authorized Representative Agreement
Because of the increased responsibilities and the significantly increased liability, the Manufacturer and the Authorized Representative will need to adjust their existing agreement. Additionally, the Manufacturer must expect that the Authorized Representative will insists on being closely involved with all regulatory compliance issues.
You probably already started the process to review your existing agreements in view of the new MDR/IVDR. If you haven’t started yet, we suggest you get going immediately.
If you have not yet entered the EU market, find an Authorized Representative committed to work under the MDR/IVDR. A rule of thumb is to make sure that the Authorized representative is independent of your physical supply chain. Do not appoint an importer or a distributor as your Authorized representative. It is better to keep as much distance as possible between your supply chain and your Regulatory Affairs. In doing so, you will be able to change Importers or distributors based on market forces. And you will be able to make such a change with minimal effect on regulatory issues. Already, under the new MDR/IVDR it will become yet again a little more difficult to find good partners.
In Part 2 we will discuss the impact of the new regulations (MDR/IVDR) on two other Economic Operators: the Importer and the Distributor.