EU Notified Body Timeframes And Pitfalls: Prolonged Delays In One Area And New Brexit Warnings
Just 10 notified bodies by the end 2019 with less than five months until the EU MDR deadline? Staff holidays cancelled? Non-medical products hit with extensive delays? And concerns that UK notified bodies may have to cancel existing CE marking certificates. Notified body veteran Gert Bos has stark warnings for the medtech sector in part one of a two-part Q&A.