Members endorsed the work done to harmonise Conformity Assessment Process with description of pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). It will be a basis for the EU DIGICAP project.
Team-NB-PositionPaper-MDR-Certification-Process-Consensus-Document-V2-20260604