Numerous manufacturers have appointed a distributor as their EU Authorized Representative. This may cause severe problems for several reasons. Find out, what you have to consider and how you can avoid taking steps you might regret deeply.
Why should manufacturers not appoint their distributor as EU Authorized Representative?
Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the EU Authorized Representative is assigned a pivotal role. Distributors may have difficulties fulfilling the corresponding requirements.
Read about five important points that should be considered when choosing your EU Authorized Representative
- Regulatory Compliance
- Technical File
- Incident Reporting & General Surveillance
- Independence & Neutrality of your Authorized Representative
- General Issues with appointing your Distributor
1. Regulatory Compliance
An EU Authorized Representative will be responsible for verifying that the Declaration of Conformity and Technical Documentation have been drawn up and that the applicable conformity assessment procedure has been carried out. Your Authorized Representative will have detailed knowledge of all the individual Regulations of each of the EU member states.
2. Technical File
Your EU Authorized Representative will have to retain a copy of your Declaration of Conformity, Technical File and relevant certificates and must allow the competent authorities of all EU member states access to that information and data.
3. Incident Reporting & General Surveillance
Your EU Authorized Representative will be aware of incidents in all EU member states. He will handle sensitive product information, like European market information, distributor lists etc. An Authorized Representative may be required to make decisions that are contrary to a distributor’s interests, such as product recalls. As such, the Authorized Representative must be able to decide independently and to your best regulatory interests at all times.
4. Independence & Neutrality of your Authorized Representative
An EU Authorized Representative must remain neutral in all actions, including being neutral towards possible competitive distributors.
5. General issues with appointing your distributor
One should be aware of the inherent risk in appointing one of your European distributors. This practice will inevitably lead to a hierarchical situation amongst your distributors, those not appointed as Authorized Representative would perceive themselves as less significant, especially as only the Authorized Representative’s name appears on the labeling.
As it is a legal requirement to include your Authorized Representative’s details on your labels and packaging, changing your Authorized Representative is expensive, inefficient and cumbersome. It involves the reprinting of labels and packaging with the new Authorized Representative’s details, as well as scrapping of all printed stock on hand. It is strategically prudent to appoint an independent representative at the outset thus avoiding unnecessary complications, expense and discontentment later.