Medical Devices Regulation (IVDR) has been adopted on May 25, 2017 and will replace the In Vitro Diagnostic Medical Devices Directive (IVDD). There is a transition period of 5 years making the Regulation fully applicable on May 26, 2022. There are massive changes compared to the IVDD confronting manufacturers with numerous challenges.

• Appoint your European Authorized Representative
• Identify all EU Directives/Regulations applicable to your product (such as IVDR, WEEE, EMC etc.)
• Select and perform the conformity assessment procedure applicable to your product
• Check your device against the General Safety and Performance Requirements (annex I)
• Identify the applicable harmonized standards for your product
• Prepare a Technical File (annex II and III) and implement a Quality Management System
• Select a Notified Body (except for class A) and sign your Declaration of Conformity