IVD Regulation – Flowchart

Overview of requirements under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU

This flowchart has been prepared by MedTech Europe as a ‘high-level overview’ of the requirements of the Medical Devices Regulation.

While MedTech Europe considers the information herein to be reliable it makes no warranty or representation as to its accuracy, completeness or correctness. This flowchart is intended for informational purpose only and should not be construed as legal advice for any particular facts or circumstances. MedTech Europe reserves the right to change or amend the flowchart or any parts thereof at any time without notice.

For more information please contact the regulations & industrial policy department: [email protected]