March 21, 2016
The CE Marking process and Factory CRO
The CE-mark serves the goal of free movement of many goods throughout the European Economic Area. You may have seen the mark somewhere, for example on the back of your phone, your laptop or a toy product. The display of the CE-mark on a medical device means that the device meets all applicable requirements of European Directive 93/42/EEC, or Medical Devices Directive. This Directive dictates a particular result that needs to be achieved, without dictating the means of achieving this. For example, one dictated (Essential) requirement in this directive is to have a Quality Management System in place – click here for more information.
Many studies conducted under contract of Factory CRO serve the goal of gathering safety and efficacy data in order to, eventually, CE-mark the medical device. For medical devices classified as IIa and higher, the requirements for these studies are usually determined in cooperation with a Notified Body. The Notified Body is an independent third party which is delegated by EU Member States for the conformity assessment of products. It is the party that certifies the manufacturer for meeting all CE-marking requirements. Examples of Notified Bodies for medical devices are The British Standards Institution (BSI) and the various Technischer Überwachungsverein (TÜV).
After the manufacturers and Notified Bodies agree upon the strategy towards CE-marking, this strategy will be put into practice. Factory CRO may provide several types of services here, including monitoring, regulatory services, data management activities, etc. Subsequent to these specific trials, the process of self-certification, in which the manufacturer declares the product conform the Medical Devices Directive, will be conducted and the medical device can be marketed.
Recommendation: Your medical device may require conformity assessment by a Notified Body before self-certification of the product for marketing in the European Economic Area can take place. Learn more? Click here
By Leonie van de Kamer and Tim Sinnema