What in the world is an EU Authorised Representative?
The basic principle of the EU product legislation is that no matter of the origin of the product, it needs to comply with EU legislation.
In medical device sector it means products must comply to the EU Medical Device Regulation.
In general, the Authorities in EU have the obligation to oversee this compliance when products are imported to EU.
In medical device sector, part of these Authority duties has however been given to an actor called EU Authorised Representative.
In practice, EU Authorized Representative performs some of the required compliance checks, and acts as a link between EU Authorities and non-EU medical device manufacturers.
What does the EU Authorized Representative do?
There are quite a few tasks that EU Authorized Representative is obliged to perform.
These tasks include verification that the EU Declaration of Conformity and Technical Documentation have been drawn up, checking that a conformity assessment procedure has been carried out for higher risk class devices. They are also the gate keepers in EUDAMED, being responsible for verifying that the non-EU manufacturer has complied with the EU registration obligations.
On top of these EU Authorized Representative is responsible for the Competent Authority correspondence for providing them with all the information and documentation necessary to demonstrate the conformity of a device. This is to be done in a language determined by the Member State concerned.
Additionally, EU Authorized Representative forwards to the manufacturer any request by a Competent Authority for samples, or access to a device and verifies that the Competent Authority receives the samples or is given access to the device.
In addition, EU Authorized Representative shall cooperate with the Competent Authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices, and in informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents
Last, it is to be noted that the EU Authorized Representative is legally liable for defective devices on the same basis as, and jointly with, the manufacturer.
Are small companies or low risk class devices exempted from designating EU Authorized Representative?
We are a very small company, and our device is low risk, do we still need an EU Authorized Representative?
Yes, you do. It is the law. Requirement to have a designated EU Authorized Representative is regardless of the company size or the product class.
If you are a medical device manufacturer located outside of the EU, and you want to place your device on the EU market, you must have an EU Authorized Representative. There is no relief for micro or small enterprises.
It also does not matter if your product is of Class I, Class Im, Class Is, Class IIa, Class IIb or Class III, you need an EU Authorized Representative as a non-EU manufacturer if you want to place your device on the EU market.
We have sales office in the EU, do we need an EU Authorized Representative?
Simply put, every medical device manufacturer located outside of the EU are obliged to have an EU Authorized Representative
Even if you have an office within the EU, you need to designate EU Authorized Representative fulfilling the conditions set in EU MDR 2017/745.