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EU Commission Issues A Last-Minute Implementing Regulation For Notified Bodies

 
• By Amanda Maxwell

Some 20 notified bodies were due to apply for designation under the EU's new Medical Device and IVD Regulations on November 26, and more after. The European Commission published needed codes for the process just one day before the application process began. Could that have created a hold up?

The European Commission has published its first implementing act under the Medical Device and IVD Regulation addressing notified body designation. It details the list of codes and corresponding types of devices so that notified bodies can specify their intended scope when they apply for designation under the Medical Device and IVD Regulations.

The Implementing Regulation EU 2017/2185 appeared in the November 24 edition of the Official Journal of the EU....

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