For medical device/IVD manufacturers, regulatory affairs, QM, and market surveillance processes often take up an enormous amount of capacity. As a regulatory affairs expert, CEyoo is a reliable partner at your side to relieve you of this burden.
- CEyoo as distributor: Take over the manufacturer’s responsibility for MDR/IVDR & Co.
We take full manufacturer responsibility for your medical product in accordance with EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). This means that we provide the manpower and process landscape for a functioning quality management system and ensure professional documentation and post-market surveillance.
This relief can not only accelerate the market entry of your products but is also an attractive solution for various groups of manufacturers: for those facing time constraints due to MDR/IVDR and/or seeking new solutions for their OEM-PLM systematics; for manufacturers with a smaller product portfolio, such as startups; and for companies looking to acquire startups and rapidly enter the market – CEyoo is the right partner for you.
- CEyoo as EU Authorized Representative/EU-REP: Your Key to the European Market
You are a non-EU manufacturer and wish to distribute your medical devices or in-vitro diagnostics (IVD) in the European market? In that case, an EU-REP (EU Authorized Representative) under Article 11 of the European Regulations for Medical Devices (MDR) and In-vitro Diagnostics (IVDR) is essential.
CEyoo is your trusted partner as an EU-REP (European Community Representative (EC-REP) or European Authorized Representative (EAR)), taking on all related responsibilities. We ensure that you effortlessly meet the requirements of MDR and IVDR, facilitating smooth access to the EU market.
Contact us for more information on how CEyoo can minimize your regulatory burden and pave the way for successful market access.
