MDSS can manage your EUDAMED registrations on your behalf. Building on decades of experience with national and European device databases, MDSS offers a full-service EUDAMED registration solution — from initial setup to ongoing maintenance.
Devices must be registered in EUDAMED by 28 May 2026* to ensure continued market access in the EU. As EUDAMED is a public database, customers, distributors, and authorities will increasingly consult it to verify regulatory compliance.
EUDAMED registration is not a one-time activity. Manufacturers must establish new internal procedures and train staff to create, maintain, and continuously update device registrations. This is a complex and ongoing regulatory obligation that requires dedicated expertise.
On 16 December 2025, the European Commission published a Proposal to amend Regulations (EU) 2017/745 and (EU) 2017/746, aimed at simplifying requirements and reducing administrative burden for medical device and IVD manufacturers. Importantly, the proposal strengthens the manufacturer’s ability to outsource EUDAMED registration activities to their Authorised Representative.
You focus on your business — we handle the registrations.
We are here for you under: Eudamed@mdssco.com
*November 28 2026 under certain conditions
