Service
Product Registration Service
As the EU, UK and Switzerland do not have the same regulatory regime, each of these target markets requires a separate registration of your products. We help you to register your products in the national databases.
Why Product Registration Matters
Product registration serves as the gateway for medical devices to enter the market and be made available for clinical use. It is a regulatory requirement aimed at safeguarding patient safety, ensuring product effectiveness, and upholding quality standards.
By registering their devices, manufacturers demonstrate compliance with relevant regulations and provide assurance to regulatory authorities and end-users regarding the safety and performance of their products.
European Union
With the launch of the EUDAMED platform, the registration requirements for medical devices may change for manufacturers. Currently, some countries of the EU require additional registration for medical devices and some specific requirements for cosmetic products to be distributed on their market.
We advise you not to have your products registered in national databases by third parties such as distributors. Instead, contact your EC-REP, such as MedNet EC-REP, for any regulatory questions.
For these reasons in particular, you should entrust a registration exclusively to your EC-REP:
- You have control over the registration - By registering in your name, YOU give up a significant amount of control over your product in the target market. In the EU, these registrations remain your property.
- You remain independent of distributors - You are still free to choose and change your distribution partners.
At MedNet EC-REP, we help you navigate the complexities of EU product registration for medical devices and in-vitro diagnostics and support you so you can focus on selling your product.
Ready to bring your medical device or IVD to the European, British, or Swiss market?
Our team of experts is well-equipped to navigate the regulatory landscape and ensure your product meets all necessary requirements.
Don’t let regulatory hurdles slow you down. Contact us today and let’s accelerate your market entry together.
Frequently asked Questions
Eudamed stands for "European Databank on Medical Devices." It is a secure, web-based platform developed by the European Commission to implement the requirements of various European Union (EU) regulations related to medical devices.
Eudamed contains various types of data related to medical devices, including information on manufacturers, authorized representatives, importers, distributors, and the devices themselves. It also includes details on clinical investigations, vigilance reports, market surveillance activities, and other relevant documentation.
Manufacturers, authorized representatives, importers, and notified bodies operating within the EU medical device market are required to use Eudamed to fulfill their regulatory obligations. Additionally, competent authorities and the European Commission utilize Eudamed to access essential information for regulatory purposes.
Eudamed will become mandatory for all medical devices placed on the EU market, regardless of their classification or risk level. It will play a crucial role in ensuring compliance with EU regulations, such as the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).