159 days until the new Medical Device Regulation

Chemical Characterization according to ISO 10993-18
On the 26th of May 2020 the ISO 10993-18 will play a major role in the MD registration. For all MD a chemical characterization will be required. This change also includes a lot of advantages for the MD producer.

1. Are there any extractables or leachables in my product and are there above or below the TTC?
2. The results lead to a better understanding and interpretation of study results.
3. With the outcome of the ISO 10993-18 for your product it will be possible to avoid extra testing and so saving time and money.
4. Study designs can be adapted more individually.
5. Changes in product composition can be done more rapidly because of the exact determination involved components.