- EC Rep for medical devices and in-vitro diagnostics
Authorized Representative – Partner for Market Success
Manufacturer and importer partner
Best friends? Not just for manufacturers, but also for importers of medical devices. Why?
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.
Must haves – The key responsibilities of the Authorized Representative as defined in Article 11
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:
- To verify the EU declaration of conformity, that the technical documentation has been drawn up by the manufacturer and the right conformity assessment procedure has been carried out by the manufacturer;
- To acquire and hold a copy of the technical documentation, relevant certificates and the declaration of conformity and provide the necessary documentation to the competent authorities in the respective language required by the member state;
- To verify that the manufacturer has complied with his registration obligations;
- To forward information from authorities, the market and the patients to the manufacturer;
- To cooperate with the authorities in any case of risk mitigation measures or reports from the market regarding incidents
The first contact point for competent authorities, importers, distributers and the market should be qualified
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.
What manufacturers and importers should expect from the authorized representatives
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:
- The authorized representative is designated and labeled on the device,
- The device is labeled in accordance with the respective regulation - Meaning, the instruction the instruction for use must be available in the respective language required,
- The UDI has been assigned and the respective registration obligations regarding the device has been fulfilled by the manufacturer
How to get in touch
A new generation of Authorized Representatives
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.
What the qtec Eurep GmbH as competent Authorized Representative can do for you:
The core responsibilities of the authorized representatives according to article 11 of the MDR/IVDR
- Check on your technical documentation and provide you with all information needed to comply with the requirements in the european market
- To acquire and hold a copy of the documentation for competent authorities
- Check on your registration obligations in Europe and (if you wish) take on this task for you
- Be the first contact for competent authorities in case of any questions and requests
- Inform you about any complaints and reports from patients, costumers or users
Furthermore we can provide you with a lot of additional benefits:
- Guide you through your communications with competent authorities and notified bodies.
- Keep you up to date with regulatory requirements and updates within the EU and all over the world if required.
- Guide you through additional national requirements regarding registration issues in the respective member states of the EU.
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:
- Catching up with your requirements coming from new and/or updated European standards
- Helping you close gaps in your technical documentation or your quality management system
- Provide training or expert opinions on regulatory- or design control topics like e.g. risk management, validation or usability
- Offer services like creating clinical evaluations or post-market-surveillance activities,
- Be on your side to choose importers or business partners in Europe or in the international market
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
