Basics of EU Authorised Representative
The European Union requires any foreign manufacturer from outside of the European Union who intends to place their devices in any of the Member States to designate an authorised representative (EC REP) with a physical address within one of the Member States. Article 11 of the Medical Device Regulation (MDR) states:
"where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer"
Under MDR and the IVDR, the EU Authorised Representative has more responsibilities than previously under the 'old' Directives. As per Article 11 of the MDR, the Manufacturer and the EU Authorised Representative should agree to the specific tasks in a mandate which the EU Authorised Representative will undertake on behalf of the Manufacturer.
Under these new regulations, the EU Authorised Representative role is not a 'post-box' service. In fact, they are obliged to undertake specific compliance tasks which cannot be delegated or outsourced - click here to read the responsibilities of an EUAR.
Bearing in mind this information, we are often asked which countries or manufacturers require an EU Authorised Representative?
From the definition mentioned above, one can identify that companies or medical device manufacturers located outside the European Union who intend to sell their innovation within the European Union will require an EUAR – European Authorised Representative. It is clear that manufacturers within the EU/EEA/EFTA do not need to appoint an EUAR, but these companies might require a PRRC – Person Responsible for Regulatory Compliance.
Besides selling the device, a manufacturer must appoint an authorised representative even if they wish to conduct a Clinical Investigation within the European Union Territories. A hasty decision might lead to wasteful expenditure. While selecting an EUAR, look for service providers who support you in all situations and will be your risk partners.
While discussing the role of EUAR, we are quite frequently asked about the consequences of not appointing an EUAR.
According to MDR and IVDR guidelines, it is a mandatory requirement for manufacturers to appoint an authorised representative if they wish to enter the European Market with their medical innovation.
If you do not appoint a EUAR:
- Your Notified Body will not issue an EC certificate for your medical innovation. [Mandatory certification for legal marketing and selling of your medical innovation]
- If you ship the products without a rep, border security authorities have the power to stop the shipment.
Why risk your medical innovation?
Once an EUAR is appointed, the Legal Manufacturer must display the details of their EUAR on the device packaging label.
The product packaging should have the EUAR's
- Contact Number
Before MDR and IVDR, an EUAR tended to be seen simply as a post-box address. But with the incoming of these significant regulations, the responsibility of the EU Authorised Representative has increased so that they have legal obligations which match that of the non-EU manufacturer.
When you select Med-Di-Dia as your EUAR, our experts commit to being your regulatory risk partners and support all our clients with complete regulatory compliance.
This is because, as an EUAR service provider, our organisation will be audited by Competent Authorities and Notified Bodies.
Why do EU Authorised Representatives get audited?
This is because the Regulators consider the EUAR to be equally liable with the Legal Manufacturer for the devices placed on the EU market. It is essential for the EU Authorised Representative to have all documents readily available and accessible at their EU headquarters. The EUAR must manage all required documentation, and since it is a role with responsibilities equal to the Legal Manufacturer, it is critical to engage with a trusted EUAR.
Many manufacturers establish a European business entity that acts as the EUAR. Based on the MDR and IVDR requirements, such entities will need to appoint a PRRC – Person Responsible for Regulatory Compliance.
Instead of establishing a new legal entity in Europe, many non-EU manufacturers appoint their product distributor as the EUAR. If you are thinking about this, please let us caution you well in advance!
It is often seen that there is a conflict of interest for the distributor to act as both distributor and EUAR. This is because the distributor will find it difficult to be truly objective as they, themselves, will be wanting to ensure sales are profitable and may put profit before safety and continual improvement.
Additionally, suppose there are any complaints against the product? Will the distributor, in their EUAR capacity, really investigate and address these complaints in a truly objective manner?
When you bear in mind the need for a distributor to make profit on sales, it’s clear that an EUAR is preferable as they will be a ‘neutral’ and independent party whilst carrying out their obligations under the MDR and IVDR.
Afterall, the EUAR has no financial interest in product sales. A distributor, however, might continue selling the product because there is financial benefit to do so. As the focus of both the legal manufacturer and distributor tends to be on sales and profit, unwittingly they may alter a product’s intended purpose and thereby its risk classification. If this should happen, they would be in breach of the regulations with immediate effect.
For an EUAR, however, compliance with the applicable regulatory requirements is the key objective and invariably, compliance will result in more sales for the legal manufacturer and distributor longer-term. The regulations might dumbfound a distributor, but the EUAR will not be ‘fazed’ because they are the specialist in this space. They will provide regulatory protection for the device enabling safe use for the end-user and compliant commercialisation for the device owner.
Appointing a distributor as an EUAR might be an easy and relatively cheap option for the Manufacturer but could cost a fortune if regulatory affairs are mishandled or not managed appropriately. Non-compliance with mandatory regulatory requirements is a serious and punishable offence - it’s definitely not for the faint-hearted!
Selection of the EUAR is a very important decision which, if not carried out with due care, could be a manufacturer’s downfall. Our experts would love to engage with you for the long-term and can guide you through our EUAR onboarding process so that you are confident your company will be properly and fully represented in Europe.
Why hamper the growth and expansion of the product and let regulations affect your innovation process when our experts are here to be your regulatory risk partners for medical devices, diagnostics and digital health! Send us an email at email@example.comBack...