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"Inside the EU medical device regulation"

Despite the MDR going into effect, key parts of the necessary infrastructure are still not fully operational, creating challenges in particular for small- and medium-sized medtech companies.

While device makers have resolved some of the near-term pressures, they still face a range of uncertainties and potential problems.

INCLUDED IN THIS TRENDLINE

• UK shares roadmap for creation of new medtech regulatory framework
• EU MDR costs could cause device shortages for children, medical groups warn
• MedTech Europe says MDR, IVDR framework needs ‘structural reform’

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