The EU regulations 2017/745 (MDR) and 2017/746 (IVDR) confront medical device manufacturers with enormous challenges: In order to be allowed to place medical devices or in vitro diagnostics (IVD) on the EU market and keep them there successfully, complex processes such as quality management, documentation (CE marking) and post-market surveillance (PMS) must be mastered. For the import of medical devices/IVDs into the EU, it must be ensured, among other things, that they are correctly CE-marked and include instructions for use, but also that an EU declaration of conformity has been issued and that the non-European manufacturer has a responsible person based in the EU (EU-REP/EC-REP) for the medical devices/IVDs to be imported. This is where we come into play:
Our teams are familiar with all regulatory affairs processes. We support manufacturers efficiently in bringing their innovative ideas to an international market.
Jörg Ohmer, Head of Business DevelopmentCEyoo takes over the manufacturer responsibility for European and non-European manufacturers. Furthermore, we act as the European authorized representative (EU-REP/EC-REP) for non-EU manufacturers in accordance with Art. 11 MDR/IVDR.
CEyoo as a Distributor
CEyoo takes care of your regulatory tasks according to EU-Regulation 2017/745 (MDR) and 2017/746 (IVDR) - from planning to documentation. You can focus on your core business while we bring your medical devices and IVDs to market. You can rely on our competence and expertise for your success.Your Relief - Our Responsibility: Discover more
CEyoo as an EC REP
You are not based in the EU? CEyoo acts as your EU-authorized representative (EU-REP/EC-REP) according to art. 11 MDR/IVDR and takes over your regulatory tasks in the EU. This allows you to fully concentrate on the distribution of your medical devices and IVDs - we are handling the regulatory affairs.Your supreme access to the EU market: Find out now
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Your benefits with CEyoo
Shorten time to market: Thanks to our regulatory affairs infrastructures, you bring your medical products to market faster and benefit from competitive advantages.Quick ROI: No need to build the necessary infrastructures, no regulatory capacity restrictions: you get to ROI in less time.Full compliance: We keep track of the latest regulatory requirements for you so that your products always remain on the market.Expertise and experience: With corporate processes precisely tailored to the requirements as a distributor / EC-REP, more than 60 bright minds and over 20 years of experience, we support you competently and reliably.