The Medical Devices Introductory Course 2020

The CE Mark

The CE Mark on a medical device indicates compliance with EU regulatory requirements for quality, safety and performance (not efficacy)

The CE Mark is affixed by the ‘ Manufacturer ’ and not by a Notified Body (NB) nor by the EU Commission nor any Member State Competent Authority

Where a NB has been involved in the device assessment then an Identifying Number for that NB is included next to the CE Mark on the product labelling

So, How Do You “Obtain” The CE Mark?

• Qualify your medical device - do you need a CE Mark? • Is it a medical device? Define intended purpose / primary mode of action • Classify your medical device

• Decide on the “conformity assessment” route

• Implement quality management system; contract with NB (if needed) • Conduct and document design development and testing; demonstrate compliance with the “Essential Requirements” / “General Safety & Performance Requirements” • Sign a Declaration of Conformity (obtain certification from NB and/or submit documentation to NB / regulatory body, if required)

• Attach the CE Mark , register and launch … But, don’t forget … post-market compliance ...