Summary and Respondent Demographics

MDR & IVDR Compliance

Introducing the MedTech 2020 Report...

As we enter 2020 with fewer guidance documents and certified Notified Bodies than expected, the preparation for the EU MDR is more crucial than ever. With only a few more months on the clock, is industry ready? Can companies be truly prepared with so much still to be decided with the EU MDR? Do Notified Bodies have the capacity and time to handle all MDD and EU MDR certificates heading their way? Meanwhile, we are half way through the IVDR implementation period. How can IVD companies learn from EU MDR implementation procedures?

MedTech Summit recently conducted (Feb 2020) one of the biggest surveys of its kind, asking these questions to medical device and IVD professionals around the world. This final report based on 265 responses reveals unique insights into the readiness of industry today as we head towards the key 2020 and 2022 deadlines, as well as the biggest challenges and how industry insiders are tackling them.

Click on any of the graphics throughout this report to interact and explore the data.

Most respondents work at medical device or software organisations

Philip Greenfield, Editor-In-Chief at Medtech Insight, introduces the report and offers analysis throughout.

"Over the last three decades, the US FDA has had a reputation for being much stricter than the EU for medtech regulation, and so the EU has been a more attractive and rapid product launch market. Now the tables have reversed.

The EU Medical Device Regulation (MDR), which comes fully into force in May, and the In Vitro Diagnostic Regulation (IVDR), which follows two years later, significantly raise the regulatory bar compared with the current EU directives."