Find your legal representative for MEDICAL DEVICE CLINICAL TRIALS.
Work with the No. 1 partner when it comes to sponsor representation in Europe, Switzerland and the UK.
or contact us at: info@fgk-rs.com
Your challenge:
You would like to start a medical device clinical trial in Europe, Switzerland or the UK and notice that for a a MD/IVD study in Europe a so-called “legal representative” is required?
What exactly does this mean for you?
A sponsor company that does not have a subsidiary in the European Union and wants to carry out a medical device clinical trial in the EU needs a “legal representative”. This applies to medical devices according to the Medical Device Regulation (MDR).
In detail: Regulation (EU) 2017/745 for Medical Devices (MDR) and Regulation (EU) 2017/746, the In-Vitro-Diagnostic Medical Device Regulation (IVDR) require that a sponsor who is not based in the EU must appoint a representative if this sponsor wishes to conduct a clinical study in the EU.
Our solution:
Highly experienced regulatory experts will provide you or your contracted local CROs with competent, quick and cost-efficient sponsor representation services within the European Union, Switzerland and the United Kingdom.
How does it work?
- Book a free consultation with our Regulatory Affairs experts.
- Get all the information needed regarding medical device clinical trials for your target market.
- Set up a contract with us to be MD/IVD Regulation compliant.
- Start your clinical study in Europe.
We may also support you with getting a SME status in the EU.
You can rely on us. We are:
focused on the individual need of our customers
flexible & fast
professional regulatory experts, each having 10+ years of experience
Book your free consultation now:
Angela Denzel
Director Representative Affairs
Your successful clinical development is our goal. You can rely on our expertise. The familiarity of FGK`s team in a frequently changing regulatory environment is an excellent basis for a long-term partnership.