New EU Regulations on MD and IVD: Don't wait until the last minute...

Find out more information about the soon mandatory laws in this paper created by our specialists and get your EU Regulatory affairs right

Currently medical devices and in vitro diagnostics are subject to the trinity of long-standing directives—Medical Device Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD), and the Active Implantable Medical Device Directive (AIMD).

These regulations  affect the device manufacturers but also any party that is a part of the supply chain or providing service activities. The regulatory changes are driven by a need to strengthen the regulatory platform, standardize and harmonize information and create a safer environment for patients and users. The two new regulations have been in a transition period since 2017, allowing manufacturers, authorities and notified bodies to get ready to adhere to the changes that will apply in full from 26 May 2022 for the IVDR and 26 May 2021 for the MDR (as it was postponed due to the Covid-19 pandemic).

What are the main changes to the MDR? New EU Medical Device Regulation: everything your life sciences company needs to know…

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