MTAA Event | EU Medical Device Regulation | Transition Update

2:00pm Thursday, 27 June 2019
4:30pm Thursday, 27 June 2019
Dentons Australia
Level 16, 77 Castlereagh Street
Sydney, New South Wales 2000

The transition to the new regulatory framework for medical devices in the European Union has been slow and challenging.

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.

Come and hear Diana Kanecka, MedTech Europe Manager International Affairs, provide us with an update on the transition status and answer your questions.

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.

The Details: 

Date:Thursday, 27 June 2019
Time:14:00-14:15: Registration (incl. light refreshments)
 14:20-16:20: EU Medical Device Regulation Update
Venue:Dentons Australia
 Level 16
 77 Castlereagh Street
 Sydney NSW 2000
Cost:MTAA Member: $95.00 pp
 Non-Member: $120 pp

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Contact Information

Lorraine Hendry - Events & Program Manager