5 Questions Industry Professionals Should Ask About the EU MDR Rollout

As the May 2020 deadline approaches, the medical device industry must prepare for far-reaching changes.

By Mike Edwards, Director of Product Management, Sparta Systems, January 2019

The upcoming European Union Medical Device Regulation (EU MDR), sets high standards of quality and safety for medical devices produced in or supplied to Europe. It will replace the EU’s current Medical Device Directive (MDD) and the EU’s Directive on active implantable medical devices. As the May 2020 deadline approaches, the medical device industry must prepare for far-reaching changes.

While the EU MDR helps clarify ambiguous elements of the previous MDD, the regulation and its anticipated rollout have generated feelings of uncertainty within the industry. Many manufacturers have specific questions on the scope and definition of the changes.

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