One-Stop Shop: EU Devices And Diagnostics Regulatory Outlook Through May 2021

Change, change and more change: Is timely compliance with the EU's MDR and IVDR still possible?

The end of the traditional EU holiday period is nearing, and the pace of regulatory activity is expected to pick up sharply as September gets underway. What can medtech expect for the rest of 2020 and into the first half of 2021, in these unprecedented times?

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During the first eight months of 2020, politics and pandemic panic heavily influenced the regulatory momentum of the medtech sector. Companies flexible enough and with sufficient resources to adapt to the changing demands and landscape are most likely to weather these storms. But we are constantly warned that not all will. Many feel battered by constant change and are unprepared. That is especially the case among SMEs, which make up 90-95% of medtech companies.

So where are we now? And how can industry best prepare for nine months until 26 May 2021, the date...

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