Good news for manufacturers of Class I medical devices: When registering devices in EUDAMED, providing a complete list of EU Member States where a device is made available or is intended to be made available is optional. This reduces the administrative effort required for data entry and maintenance, particularly for manufacturers with extensive product portfolios.
Which Information Is Mandatory?
The Medical Device Regulation (MDR) distinguishes between different risk classes regarding market information:
- Class I: Providing a complete list of countries of availability is optional.
- Class IIa, IIb and III: Specifying the Member States where the device is made available or is intended to be made available is mandatory.
Important: Even for Class I devices, the Member State where the device was first placed on the EU market must be specified when the device status is “On the EU market”. The optional requirement therefore applies only to the additional list of countries of availability.
Updating Countries of Availability
Another advantage is that voluntarily provided countries of availability can be added or updated at any time without creating a new version of the UDI-DI record. Market information is versioned separately.
Reduced Administrative Effort for EUDAMED Registration
For manufacturers of Class I medical devices, this simplifies data maintenance. A complete list of countries is not required for this risk class, while mandatory information regarding the placing of the device on the market must still be provided.
Legal and technical references: Regulation (EU) 2017/745 (MDR), Annex VI, Part A, Sections 2.3 and 2.4, and EUDAMED Business Rules BR-UDID-043, BR-UDID-045 and BR-UDID-630.
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