CEyoo - Your distributor / European Authorized Representative for Medical Devices and In vitro Diagnostics (IVD)
Our regulatory affairs infrastructure is built on a solid foundation, and we are ready to set you free from all the regulatory burdens and accelerate your target objective:CEyoo takes over the temporary placing on the market of your medical devices/IVDs and is at your service as a European Authorized Representative (EU-REP) according to Art. 11 MDR/IVDR. Discover the possibilities of a smooth certification and a successful market entry. Welcome to CEyoo - your partner for regulatory relief and successful market access in the EU!
CEyoo has already installed the entire regulatory affairs workflow and infrastructure. The risk of delays in market entry is minimized, and the product reaches the market faster. CEyoo offers calculated security in often unknown territory.
Our mission: Regulatory Relief - for your company
CEyoo as distributor of your Medical Device/IVD
CEyoo takes over the regulatory tasks and duties of the manufacturer for you in terms of the EU Regulation 2017/745 (MDR) or 2017/746 (IVDR).This includes the efficient planning, implementation, and documentation of quality management, authorization, and market monitoring. Meanwhile, you can invest all your energy in your core business.This is how you benefit from this offer
CEyoo as your European Authorized Representative (EC-REP)
Are you a non-EU manufacturer and are planning market access in Europe? Then Ceyoo will take over your regulatory tasks in the EU as your regulatory tasks in the EU as your European authorized representative (EU-REP/EC-REP) in accordance with MDR/IVDR Art. 11. You concentrate fully on the distribution of your medical devices/IVDs, you have us for all regulatory issues.
Discover how we can take the burden off your shouldersDiscover how we can take the burden off your shoulders
We meet the regulatory requirements for your medical devices and in-vitro diagnostics (IVDs) in the challenging times of today.
CEyoo GmbH is a subsidiary of the regulatory compliance service provider Metecon, which means that we have over 20 years of experience and more than 60 experts in all regulatory topics.Our manufacturers are at the center of CEyoo. We take the regulatory burden off their shoulders, so they can focus their energies on their innovations and their sales.Find out now how we achieve your regulatory relief