11.00 Welcome and introduction - Lynda Wight, TOPRA, and Dr Wolfgang Lauer, Head of Medical Devices Division and Medical Devices Research Group, BfArM, Germany
11.10 - 12.40
This session will cover the revision of the EU Medical Device Directives. It will provide an overview of the future regulatory framework, discuss the key changes proposed in the regulations and examine the consequences of these changes and the impact they will have on notified bodies and companies working with these products. An outline of where we are currently and the next steps in the revision process will also be given.
13.40 - 15.10
This session covers the regulation of combination products as medical devices or medicinal products depending on principal mode of action and presentation. It discusses pertinent regulations, eg, reference to Annex 1 of the Medical Device Directive and possible changes due to the revision. The session also outlines some of the regulatory challenges facing those developing combination products and the importance of human factors and usability testing to reduce user error.
15.50 - - 17.15
The session will look at the regulatory challenges posed by the rapid development and deployment of advanced healthcare software. The potential gains for clinicians and patients are alluring but real dangers exist in placing over-reliance on software which may have dubious providence. Apps, cloud-deployment, cyber-security, ergonomics and network integration pose numerous regulatory dilemmas in controlling products without stifling innovation.
17.20 TOPRA Board update and student poster winners announced
18.00 Networking drinks in exhibition hall
09.00 - 10.30
This session will cover the use of different vigilance instruments and projects with respect to their further development and use. You will hear from leading competent authorities in Europe on how their vigilance system is running, what challenges are to be dealt with and what European projects with respect to vigilance are on the horizon on the way to the new medical devices ordinance.
Clinical Evidence is a prerequisite to the marketing of any medical device. The results of a well-conducted clinical evaluation (literature review) and or a Clinical Investigation is a key part of obtaining regulatory approvals for medical devices on a global basis. A clinical evaluation should be conducted for all medical devices for CE marking unless there is due justification and the clinical data requirements can be met by other means. Where suffcient clinical data is not available or in cases of high risk devices a clinical investigation may be neccessary. This session is intended to provide different perspectives on the clinical evaluation from a notifed body and industry viewpoint. It also covers the notification process and conduct of a clinical Investigation in Germany. Delegates will learn how to conduct a clinical evaluation and ensure it is suitable for both the notifed bodies and the regulators and also how to notify a clinical investigation in Germany.
13.15 - 14.45
This session covers the revision of the EU In Vitro Diagnostic Directive and provides an overview of the future regulatory framework. It discusses the key changes proposed in the regulations and examines the consequences of these changes and the impact they will have on notified bodies and companies working with these products. An outline of where we are currently and the next steps in the revision process are also given.