As stipulated in Article 11 of the new Medical Device Regulation (EU) 2017/745 (MDR) and the Regulation for In-Vitro-Diagnostic Devices (EU) 2017/746 (IVDR), in case the manufacturer is not established in a member state of the European union, he must designate an authorized representative before he is allowed to place devices on the European market.
This is not a new requirement, but the tasks and responsibilities of this authorized representative were not defined in detail within the directives like e.g. the 93/42/EEC or 98/79/EEC before. And in addition, both new regulations define clearly that the manufacturer`s responsibilities cannot be transferred to another party.
Within the regulations, there are some „must haves“; these are known as key responsibilities. These responsibilities state that the mandate requires the authorized representative to fulfill the following tasks:
When looking to get in touch with any manufacturer, the first point of contact should be through the authorized representative. This will ensure a qualified and constructive response to any question you may have.
Representatives vary in quality. We as a company have seen it all. Some of them offer cheap services and do not even bother to look at the technical documentation the receive from the manufacturers and do not respond to requests from competent authorities. And so it comes that most of the competent authorities did turn their attention, questions and requests to the importer - who often does not have the resources or deeper regulatory knowledge to handle this requests.
Additionally, the stakes for manufacturers who want to place their devices on the EU market, are higher than before. New and more detailed requirements for the technical documentation, much more active post-market-surveillance activities and complicated registration obligations.
Most manufacturers do not only need a new highly qualified authorized representative, but also a wide range of services and the capabilities to smoothly register and place products into the EU. They need a real partner for the European market.
On the other hand, the device manufacturer who's products shall be introduced to the EU must acquire a qualified authorized representative, not only for their own benefit, but for the importers as well. For the importers must verify the following points:
If the manufacturer has designated a qualified authorized representative, the importer will have less difficulty understanding the requirements, because the EC Rep has communicated every issue regarding labeling, registration or documentation to the manufacturer, before the device has been delivered to the importer.
If this is not the case then the importer will not be able to deliver medical devices before these issues are solved.
Triggered by market surveillance activities, competent authorities often get in contact first with the importer of a medical device from a non-EU manufacturer. And at this point it is crucial for the importer to have a qualified and supportive contact at the authorized representative, to take over the communication regarding device-, compliance- and / or vigilance related topics.
As a conclusion it can be said that there must be a new generation of authorized representatives. They should no longer be a warehouse for documents, but a partner for both the manufacturer and the importer of devices. Manufacturers should be choosing these partners very carefully and keep in mind that there may be great consequences for any business who's authorized representative is not careful. These kinds of mistakes could injure the trust of the market stakeholders.
The core responsibilities of the authorized representatives according to article 11 of the MDR/IVDR
Furthermore we can provide you with a lot of additional benefits:
As the qtec EuRep GmbH is a member of the qtec group, you will have access to over 60 experts from all fields of the medical devices industry, to support you in:
And of course you are welcome to our network and benefit from information about marketing events, trade fairs, technology conferences and meetings with stakeholders of the medical devices industry.
Get in touch with our General Manager Delvyn Heinsch or our CEO Jan Graf