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.
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.
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