In vitro diagnostic medical device manufacturers will soon be expected to comply with major changes in the European Union’s (EU) long-standing regulatory framework which governs market access to the EU.
The IVDR was officially published on 5 May 2017 and entered into force on 26 May 2017. Manufacturers of currently approved medical devices will have a transition time of five years until 26 May 2022 to meet the requirements of the IVDR. Under certain conditions, products already certified by a Notified Body might be placed on the market for additional 2 years. It is important to note that, as an EU regulation, the IVDR will have the force of law throughout the EU when it comes into effect. This approach should eliminate country by country interpretations of the requirements permitted under current directives.
The proposed IVDR differs in several important ways from the EU’s current directive on in vitro diagnostic medical devices. Most significant changes in the proposed regulation include:
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