Health Reform Video

The EU’s New Regulatory Framework for Medical Devices

MedTech Europe’s International Affairs Manager, Diana Kanecka, recently addressed an MTAA hosted, EU Medical Device Regulation event in Sydney.

Diana discussed the slow and challenging transition to the new regulatory framework for medical devices in the European Union.

As of June 2019, only two notified bodies, BSI UK and Germany’s TÜV SÜD, have been designated to the new EU MDR. A number of important implementation milestones are yet to be met and time is running out.


Diana Kanecka
Manager, International Affairs – MedTech Europe

Diana Kanecka works with the International Affairs team at MedTech Europe. Previously, Diana’s focus within MedTech Europe concerned medical devices and chemicals legislation. She holds a Postgraduate Diploma in European Union Law from the King’s College of London and a Master’s degree in Interdisciplinary European Studies/European Single Market from the College of Europe. Diana has a strong interest in trade policy and regulatory topics. She was also an active member of the European Health Parliament project where she worked with the ‘economic dimension of healthcare’ committee on development of recommendations on the future of healthcare systems.

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