Services
EUDAMED legacy device registration
Devices sold in the EU under an MDD or AIMDD certificate must be registered in EUDAMED by 27 November 2026, unless their MDR version is already registered (MDR Article 123(3)(e)). From your EU product list and your certificate we prepare the EUDAMED bulk-upload file for all of them, and you upload it with your own login.
- One XML file for all your legacy devices, checked against EUDAMED's XML schema
- A review workbook showing the source document of every value
- A short list of the questions your documents cannot answer
How we handle your documents: Data Processing and Confidentiality Statement.
Post-market surveillance data
Data for PMS reports and PSURs, structured following MDCG 2022-21 and delivered as Word and PDF.
- Scientific literature searches
- FDA adverse event reports and recalls
- Health Canada and UK MHRA safety notices
- Similar devices registered in EUDAMED
Declarations of conformity
Drafted and checked against MDR Annex IV, including SRN, Basic UDI-DI, risk class and notified body details.
EUDAMED data checks
Your device and economic operator registrations compared with the public EUDAMED records.
Recurring reports
Tools that produce your yearly reports from your own data, in the format you already use.
The manufacturer stays responsible for the final documents. We prepare them, and your team reviews and approves them.
Contact
Email us with a short description of your project.
Jämeräntaival 7C
02150 Espoo, Finland
