Monthly Archives: November 2023

Where to start: CE Mark for Medical Devices

When doing business in Europe it is the manufacturer’s responsibility to carry out the conformity assessment with the European standards for its range of products. Since the introduction of the MDR (European Medical Device Regulation 2017/745) and the IVDR (European in Vitro Diagnostic Medical Device Regulation 2017/746 (EU-IVDR), we understand this process for medical devices and diagnostic products has far become more complex.