Medical device product developers and manufacturers are constantly under scrutiny by regulatory organizations. Standards and regulatory bodies like the FDA, ISO and IEC may seem draconian in their approach, but is critical that they apply highest and strictest standards when it comes to life-saving products.
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Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
The Medical Device Regulation was officially published on May 5th 2017 and came into force on May 25th 2017. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the regulation. For some manufacturers the new regulation provides an additional time after the date of application allowing them to place new products for max. 4 more years on the market. Additional requirements will apply for this extended transition period. The corrigenda for the MDR and IVDR have also been made public.