A step-by-step guide to preparing for the new EU Medical Device Regulations and In Vitro Diagnostic Regulations
In May 2017, the European Parliament and Council proposed a number of important legislation changes that will improve the safety and efficiency of medical devices (MDR 2017/745) and in-vitro diagnostics (IVDR 107/746).
Described as the most disruptive change in recent industry history, these new medical device regulations will cause a massive upheaval in the manufacturing processes for all medical device companies in Europe.
What’s more, these legislation changes are expected to be applied by 2020, giving companies a limited time to become fully compliant. Failing to comply will prohibit them from being able to sell medical devices and in-vitro diagnostics in the EU. Furthermore, companies not complying will be at risk of receiving substantial penalties from regulatory bodies and national competent authorities, or in extreme cases, legal action may be taken against them.
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