The timeline provided by MDR was three years, which extends until 25 May 2020
TORONTO (PRWEB) February 19, 2020
In 2017, the EU’s revamped Medical Device Regulation (MDR) was published, which expanded the scope of regulations and requirements that currently govern medical device manufacturers under the Medical Devices Directive (MDD); the timeline provided by MDR was three years, which extends until 25 May 2020. Major changes from the previous MDD include:
- Elimination of the “grandfathering” mechanism, which necessitates that all medical devices on the market must apply to be accredited, regardless of whether or not they were previously approved under earlier directives
- Empirical evaluation and testing that demonstrates that devices are biocompatible, in alignment with ISO 10993-1:2018, and not merely relying on historical data that supports a device’s safety
- Documentation that medical devices do not contain carcinogens, mutagens, or reproductive toxic substances. This can be accomplished by identifying and quantifying the materials that compose the medical device above 0.1 percent (by weight)
- What manufacturers need to know about the EU MDR
- Overview of the scope of testing, the analytical approach and turnaround times involved to address new MDR requirements
- Three examples of the types of tests offered by Eurofins EAG, presented as case studies
- Extractables and leachables studies
- Potential follow-up steps after testing
This webinar will be followed by a live Q&A with the featured speakers.
For more information or to register for this event, visit Are You Prepared for the New Requirements of the EU’s Medical Device Regulation?
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