Unannounced notified body visits recommendation imminent – amend your contracts and procedures now!

While everybody is running around about the MDR and IVD regulations proposals another storm is brewing in the wings: unannounced audits, which I announced earlier. Currently notified bodies “may” do unannounced audits under the EU medical devices rules. Now they will be required to do a minimum amount of unannounced audits. Required? Yes, EU member states may require this as condition for accreditation of the notified bodies. Will they? Most certainly. Some have already started to require notif [...] « Read the rest of this article on medicaldeviceslegal »