Complying with the Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) brings new requirements.

According to the MDR, manufacturers should put a UDI on (the packaging of) medical devices and in some cases on the medical device itself. Also, entering product data in Eudamed, the central European database is mandatory and the assignment of a Basic UDI-DI is required to identify a product family. To identify a product model or product family, GS1 has the standard Global Model Number (GMN).

MDR Deadline

The deadline for registering EUDAMED and UDI assignment all classes of medical devices (III, IIb, IIa, I) is 26 May 2021. We recommend you put UDIs on medical devices a soon as possible so healthcare institutions can scan your products.
From 26 May 2021 the Dutch hospitals and clinics are required to register all class III medical devices.

We can help you with GS1 standards

As an accredited party we can help you comply with requirements using GS1 barcodes and GS1 Data Source Healthcare.

Manufacturers must provide all medical devices on the implant list with a UDI (Unique Device Identification) and share corresponding article data with healthcare institutions.

We can help suppliers and healthcare institutions comply with the agreements. How does that work?

For manufacturers:

Place a UDI (identification code) on all packaging of medical devices (and in vitro diagnostic medical devices) and sometimes also on the medical device itself. With GS1 barcodes (Global Trade Item Number) you can create a UDI.
Put the UDI in both text and symbol clearly and easily scannable on all packaging levels.
Identify product models and/or product families with a GMN (Global Model Number).
Exchange product data using a centralized product database with clients, such as healthcare institutions. You can use GS1 Data Source Healthcare for this.
Apply for an SRN (Single Registration Number) and LUA (Local User Administrator) to access Eudamed. (This number is issued by the MDR)

Support and guidance

As accredited party we can offer support and guidance. Whether it concerns coding, entering data or sharing knowledge: we are ready to assist you. We will be happy to help you along (free of charge). Send your email to healthcare@gs1.nl or contact us by telephone at +31 (0)20 511 38 88.