Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough decisions. You need to be aware of some key changes to the regulations –
• Device classification changes
• New classes of medical devices, including Class Ir for reusable devices.
• Lack of extensions for Class Ir
• Grandfathering in legacy devices will be strictly prohibited.
As of May 26, 2020, every Class Ir device must have an MDR CE mark to be permitted in the market.
Learn more about the new subclass for Class Ir under MDR and the necessary steps to ensure compliance in the recent MedTech Intelligence article by Dan Fowler, WuXi AppTec’s Principal Scientist for reprocessing.
“Preparing for MDR: Don’t Forget about Class I Reusable Devices” echoes countless experts on the importance of timelines and preparation. It also highlights critical components of robust validation studies for reusable devices, five rules of testing to keep in mind, reasons studies fail, and more.