CE Marking Medical Devices - European Commission Recommendation of 24 September 2013 (2013/473/EU)

BSI unannounced auditsEuropean medical device regulations are undergoing many significant changes that will impact manufacturers, suppliers, and Notified Bodies. One major change that has already impacted the medical device community is the EU Commission requirement for Notified Bodies to conduct unannounced audits on manufacturers of CE marked products, which was introduced in 2014.