What is the European Medical Device Regulation – EU MDR?
The European Medical Device Regulation (EU MDR) is intended to ensure a high standard of quality and safety for medical devices being produced in or supplied into the European Single Market. It came into effect on 26 May 2021 and is designed to make it easier to identify medical devices and improve transparency through the standardization of data and the establishment of an EU database (EUDAMED), which is planned for launch in 2022.
Similar to the FDA’s UDI, EU MDR now provides a robust, transparent, predictable, and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. It uses a new risk classification system for diagnostic medical devices based on international guidance and will improve coordination between EU member states while providing stricter pre-market control of high-risk devices at an EU level.
WHY IS IT IMPORTANT AND HOW DOES IT AFFECT YOUR LABELING SOFTWARE?
EU MDR has strict requirements for information that needs to appear on the product, packaging and Instructions For Use (IFUs), as well as introducing a requirement for an 'implant card' to be provided to patients containing information about implanted medical devices. Collectively these measures will facilitate traceability through the supply chain from its manufacturer through to the final user.
Unlike its predecessor, the regulation covers a broader range of products, including aesthetic products which present the same characteristics and risk profile as equivalent medical devices.
HOW CAN PRISYM ID HELP?
Labeling plays an essential role in EU MDR compliance and many manufacturers are currently evaluating their existing product portfolio, ahead of transition deadlines in 2024 and 2025, making decisions on whether to update them or withdraw them from the market.
The PRISYM 360 cloud-based medical device labeling software contains key functionality that will ensure EU MDR compliance for new products while easing the transition of existing SKUs. Mass change functions enable the fast and accurate update of labels, significantly reducing the cost and time involved in these processes while reducing regulatory risk.
PRISYM ID has been helping the medical device industry understand the seismic change to the medical device regulatory landscape caused by EU MDR, providing support and guidance on how to adapt labeling solutions and ensure compliance. A suite of free resources to assist you on your compliance journey is available to download, including a whitepaper, Simplifying the Path to EU MDR.