qtec EuRep GmbH
European Authorised Representative
You are a manufacturer of medical devices from a non-EU country and would like to start or continue selling your products in one of the largest economies in the world?
We are sure you already know that you have to comply with the requirements as laid out in the ‘Medical Device Regulation’ (EU) 2017/745 or the ‘In-Vitro Diagnostics Regulation’ (EU) 2017/746 and have to designate an authorised representative in order to access the European market with your safe and effective products.
And still, you have not found the right partner, yet? A partner who guides you both professionally and pragmatically through the challenging and seemingly unmanageable jungle of regulatory and technical requirements? A partner who also supports you in meeting these requirements and implementing the necessary design adoptions?
Well, now you are on a good track, as you have found us! Let us be your ‘Authorised Representative’ as required per article 11 in both regulation (EU) 2017/745 and (EU) 2017/746.
Who are we and what drives us? – the qtec group is an essential partner of medical device manufacturers, located in Germany. Under the qtec group family the qtec services GmbH as universal provider for Regulatory Affairs, Design Control and Quality Management services and the qtec EuRep GmbH as authorised representative for medical devices and in-vitro diagnostics are closely related to each other.
The well-being of the patient is our top priority. It fulfills us that with the help of our work, your products will be made available for patients safely, effectively and in time. Even if we do not develop, manufacture or sell medical devices ourselves, we are experts in ‘medical devices’ as we constantly gain distinctive knowledge while we continuously support medical device manufacturers all over the world without being your competitor.
Our vision "Your reliable partner when Europe meets the world" determines our actions.
As we have more than 85 experts at the qtec group collaborating closely together, we have the distinct knowledge to answer every conceivable question and master every conceivable task on the way to a safe medical device and its successful placing on the EU market.
As your strategic partner at hand, we assure that you as a manufacturer from outside of the EU, may start or continue selling your products. In order to make sure that you comply with the requirements as laid out in the MDR (MDD) and IVDR (IVD) we
- Position ourselves as a communication and coordination interface between you and your notified body or any competent authority in case of vigilance activities, CAPAs, complaints, or any clarification needs.
- Check your EU declaration of conformity
- Check your technical documentation and have available a copy of it, as required by MDR and IVDR
- Check your conformity assessment procedure and support you on your way, to guarantee a smooth registration procedure
- Support you with labeling requirements
And for the unlikely event that corrections are needed to your documentation or your product, we have the experts at hand to fix it!
Don`t wait any longer, get in touch with us!
- The requirements for Swiss medical device manufacturers have changed; the qtec EuRep team will tell you what you and your company need to be aware of.
- Authorized Representative - what you should expect from this key access to the market