With the new Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) replacing the Medical Devices Directive 93/42/EEC (MDD), the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD), the principle of CE Marking remains the same!
Read here, what is required to obtain the CE Mark
Whether a Notified Body was involved or not, every manufacturer has to fulfill the General Safety and Performance Requirements (SPR) in accordance with annex I and set up the Technical Documentation according to annexes II and III. Finally, every manufacturer has to complete a Declaration of Conformity in accordance with annex IV of the MDR or IVDR respectively. Manufacturers that are not located in the EU are obliged to apply for CE Marking via an Authorized Representative in accordance with article 11 of the MDR and IVDR.
Also, final compliance with the Directives and Regulations does not mean that the finishing line has been crossed. Standards are revised constantly and those manufacturers who do not actively take part in these revisions will find it impossible to keep up to date.
Upcoming changes towards the MDR / IVDR
The MDR and IVDR represent a shift from a pre-approval to a life-cycle approach. For example, data generated through post-market surveillance must feed back into a manufacturers risk management and clinical evaluation. Essential parts of the Technical Documentation must be updated regularly. Please see the corresponding section below and follow the links for further details. (Many of these points are also listed under “CE Marking” in the main navigation.)
Fundamental as well as up to date information on CE Marking in full depth
MDR – Medical Devices Regulation (EU) 2017/745
IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
AIMDD – Active Implantable Medical Device Directive No. 90/385/EEC (2007/47/EEC respectively)
MDD – Medical Device Directive No. 93/42/EEC (2007/47/EEC respectively)
IVDD – In Vitro Diagnostics Directive No. 98/79/EC
Technical File Compilation
Declaration of Conformity
Notified Body Selection and Change