Important Regulatory Update and Deadlines or Economic Operators: first EUDAMED modules are declared functional
Following the publication of Commission Decision (EU) 2025/2371 in the Official Journal of the EU on November 27, 2025, the first four modules of EUDAMED have been officially declared functional.
Six months later all economic operators (manufacturers, importers, authorized representatives, OEM/PLM distributors and economic operators with system and procedure pack processes) must be registered in EUDAMED database.
See an overview of the key dates for registration:
Registration Deadlines (Modules 1-4)
Deadlines and Who / What is affected?
May 28, 2026: Start of Mandatory Use: From this day onwards, all economic operators (manufacturers, importers, authorized representatives, OEM/PLM distributors and economic operators with system and procedure pack processes) must be registered to obtain a Single Registration Number (SRN).
May 28, 2026: New Products: Medical devices placed on the market for the first time after this date must be registered in EUDAMED before being placed on the market.
Nov 27, 2026: Existing Products & Legacy Devices: Products already on the market before May 28, 2026, must be retroactively registered by this date at the latest (12-month transition period from the declaration of functionality). |
The Affected Modules
The deadlines mentioned above apply to the following four modules, which are now considered operational:
* Actor Registration: Registration of economic operators.
* UDI / Device Registration: Product registration and the UDI database.
* Notified Bodies & Certificates: Certificates issued by Notified Bodies.
* Market Surveillance: Primarily relevant for authorities.
Important Special Provisions
* Vigilance & Clinical Investigations: The modules for Vigilance and Clinical Investigations/Performance Studies are currently not yet mandatory. These are expected to become mandatory in 2027 (targeted for Q2 / 2027), once their functionality is also officially announced in the Official Journal.
* Immediate Registration: Regardless of transition periods, products must be registered immediately if they become subject to a vigilance report or a Field Safety Corrective Action (FSCA).
h/p/cosmos recommends: Do not wait until May 2026. Since the validation of actor data by national authorities takes time, you should complete the Actor Registration as soon as possible if you haven't already. Without an SRN, you cannot upload product data into the system.
h/p/cosmos has been registered as economic operator and with h/p/cosmos medical devices at a very early stage since the year 2021:
h/p/cosmos SRN / EUDAMED ID: Economic Operator Manufacturer: SRN: DE-MF-000006147
Correct Nomenclature code: Z129006: Treadmills for physiotherapy and/or diagnostic uses
Correct Risk Class for motor powered treadmills: Class IIa and/or Class IIb based on MDR classification Rule 9 (sub-rule 10 may apply for some devices.)
Thus, h/p/cosmos is registered in EUDAMED five years before the official obligation, creating transparency and support for all parties involved.
Ahead of time… a registered trademark of h/p/cosmos.
EUDAMED is an excellent tool to help all economic operators fulfill their obligations.
On January 19, 2026, h/p/cosmos is planning a webinar with Dr. Volker Lücker, a specialist lawyer in medical device law, for all h/p/cosmos partners and customers. The webinar will focus on the responsibilities and risks of economic operators and customers, specifically regarding the incorrect risk classification of treadmills. Stay tuned for news on that.
