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Understand in a few minutes

the main changes and impacts.

Since 26 May 2021, the European regulation surrounding medical devices (DM / EU MDR) has evolved. The changes brought by this new version can have important impacts on the marketing of a new product but also on the already marketed products. In February 2023, deferrals were granted by the European Parliament for certain types of devices which have until the end of 2026 or 2028 to become compliant.

Are you struggling to keep up and looking to understand the main points and/or identify solutions in a few minutes?

Then you've come to the right place!

What are the major changes?

A summary of the key points (not an exhaustive list of changes)


Medical Device Directive (MDD) > May 2021 > Medical Devices Regulation (MDR)


To obtain or maintain CE certification, all devices marketed in the EU must comply with this new regulation


New product classification with impact on already marketed products (see our summary).


Assignment of a unique code associated with each device (Unique Device Identifier - UDI) with an obligatory declaration under the EUDAMED database before May 2022.


Addition and changes of pre-marketing requirements


Added requirement for Post Marketing Surveillance (PMS)


Major overhaul of labeling requirements

The purpose of this new regulation

With these new regulations, maintaining or launching a product on the market is coupled with an ever-increasing need for data collection, the aim being to provide relevant proof of the safety or efficacy of the devices.

The means for collecting this data must be reliable and validated, but also capable of addressing all logistical issues (in-center monitoring, real-life and continuous monitoring). To achieve this, Datacapt supports you with its new-generation data collection platform.

Ask for a demo!


Medical device classification has evolved

With the new regulation, many medical devices are moving to a new class.

Read this article to find out more about this latest development.


PMS studies and their setting up

New regulations make post-marketing studies (PMS) mandatory.

Learn more about how to implement them and for which devices.


Simplify your Medical Device and PMCF studies with Datacapt.

With Datacapt you can benefit from flexible electronic data capture solutions, in line with the EU MDR regulation. We are here to assist you in improving the security and compliance of your projects.