Preparing for EUDAMED - Europe’s Medical Device Database

In 2017, the European Commission (EC) released two new regulations, one specific to medical devices and the other for in vitro diagnostic medical devices.

The Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostics Regulation 2017/746 (IVDR) replace the existing directives and are legally-binding regulations that apply across all EU Member States.

One of the goals of these regulations is to improve the transparency and coordination of data related to medical devices marketed in the EU. To accomplish this goal, the regulations call for a multipurpose database known as the European Database for Medical Devices (EUDAMED).

Currently, EUDAMED is only partially ready, which has led to much confusion around the EU medical device community with what manufacturers need to do—and when—to meet EU MDR and IVDR requirements for EUDAMED.

In this article, we’re going to clear up some lingering questions about EUDAMED, including when you need to begin adding your medical device’s information to it, so you can prepare accordingly.

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What is EUDAMED?

EUDAMED is meant to be a living record of the lifecycle of medical devices which are sold in the EU. It’s a comprehensive online database that aims to help promote patient safety through increased transparency of both medical devices currently sold on the EU market and those that will be placed on the EU market in the future. Sounds impressive, right?

EUDAMED is made up of six modules, however, not all of the modules are currently available:

  1. Actor Registration

  2. Unique Device Identification (UDI) and Device Registration

  3. Notified Bodies and Certificates

  4. Clinical Investigations and Performance Studies

  5. Vigilance and Post-market Surveillance

  6. Market Surveillance

The Actor Registration module has been available since December 2020, and the modules for “UDI and Device Registration” and “Certificates and Notified Bodies” are scheduled to become available in September 2021. 

The remaining three modules are not yet active, and while there is no exact timeline for each of them at this time, the anticipated launch date for all EUDAMED modules is May 26, 2022; this is known as the Date of Application (DoA) and it has enormous importance for UDI and Device Registration submissions.

So far, the DoA has been delayed twice, partly due to the global coronavirus pandemic. But as of writing, EUDAMED appears to be on track for its current DoA in May of 2022.

 

What is the link between UDI and EUDAMED?

While all the modules in EUDAMED contain important information, one of the most significant is the module covering UDI and Device Registration. 

A Unique Device Identifier is a standardized means of tracking medical devices during post-market surveillance, and it helps protect patients by ensuring the traceability of devices.

Within EUDAMED, the UDI module is broken up into two parts known as BUDI-DI (Basic UDI-DI) and UDI-DI. These are numeric or alphanumeric codes used to group and track devices. The two acronyms can be confusing when used together, so let’s break them down.

BUDI-DI is a product family identifier. It’s purpose is to group devices with the same risk class, intended purpose, essential design, and manufacturing characteristics. This does not appear on the label or packaging of a device and is not used for supply chain purposes.

UDI-DI is the unique product identification for specific devices and it identifies the product within the supply chain or on the market. The acronym consists of two parts:

  1. Device Identifier - This portion of the UDI is both fixed and mandatory, and consists of a marking that identifies the specific model or version of a device.

  2. Production Identifier - The production identifier is variable and contains information such as:

    • The lot or batch number of the specific device

    • The serial number of a specific device

    • The expiration date of a specific device

    • The manufacturing date of a specific device

UDI data submission and registration of a device is expected to be a single event. These two items are linked together in a single module because both work toward the goal of tracking any medical device within the EU. From here, when I talk about registering your device, that will refer to both UDI and device registration.

 

How and when to register your medical device to EUDAMED

Due to the DoA delays, companies have an additional six months on top of the regulations’ stated 18-month period to register devices to EUDAMED, resulting in a 24-month period to register devices, in most cases. 

Assuming the UDI and Registration module meets its target date of September 2021 in which it will become active, manufacturers may begin registering devices in advance of the DoA for EUDAMED as a whole.

Additionally, if there is a serious incident, field safety notice, or field safety corrective action any time during the 24-month period, the device must be registered at that time. 

The delays in launching EUDAMED have given medical device manufacturers more time to submit their data and register their devices. Even with this extended deadline, you should be proactive in ensuring you have both the means and procedures in place to submit data quickly and efficiently. 

Using Greenlight Guru, you can control procedures related to EUDAMED, and using our Intelligent Document Management workflows, see insights into which documents may require changes as EUDAMED continues to launch.

WANT TO BECOME A MEDICAL DEVICE INSIDER? Get VIP access to the best medical device content, checklists/templates & events delivered to your inbox every week by subscribing to our newsletter now!

Stay on top of all EUDAMED requirements with Intelligent Document Management from Greenlight Guru

New data submission requirements combined with shifting timelines are enough to stress even the most seasoned medical device professionals. 

The best way to stay on top of all your documentation needs is with a QMS purpose-built for medical devices that brings together cross-functional data and provides seamless visibility and traceability into your documents and records. 

Intelligent Document Management from Greenlight Guru leverages AI and machine learning technologies to ensure that nothing slips through the cracks as you’re gearing up for EUDAMED to meet the stated documentation requirements of EU MDR and IVDR.

Get your free demo of Greenlight Guru today to see just how much easier EUDAMED compliance can be with Intelligent Document Management.


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