EUDAMED and swissdamed Registration Support
Navigating the complex regulatory landscape of medical device registration can be challenging. At confinis, we are here to support manufacturers with seamless registration to both EUDAMED and swissdamed, ensuring compliance and smooth market access.
EUDAMED (European Database on Medical Devices)
EUDAMED is a secure, web-based portal developed by the European Commission as part of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It serves as a comprehensive repository for regulatory information related to medical devices. EUDAMED aims to enhance transparency, improve coordination between EU Member States, and ensure high standards of public health and safety. All medical device manufacturers intending to market their products in the EU must register with EUDAMED, providing detailed information about their devices, economic operators, and relevant certificates.
swissdamed
swissdamed is the Swiss counterpart to EUDAMED, designed to align with the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO). swissdamed facilitates the registration of medical devices in Switzerland, ensuring compliance with national regulations. It enhances traceability and oversight of medical devices within the Swiss market, promoting patient safety and regulatory consistency.
Are you ready to register your medical devices in the EU or Switzerland?
Let confinis guide you through the process with our expert knowledge and strategic planning capabilities. Our team of regulatory affairs specialists is well-versed in both EUDAMED and swissdamed requirements, providing you with tailored support to ensure a smooth and compliant registration process.
Contact us today to learn how we can assist you in registering your medical devices and achieving regulatory compliance in both the EU and Switzerland. Let confinis be your trusted partner in navigating the complexities of medical device registration.
Together, we can ensure your medical devices meet the highest standards of quality and safety, ready for successful entry into the European and Swiss markets.
