The new European Medical Device Regulations (MDR) and the In Vitro Diagnostic Medical Device Regulations (IVDR) represent some of the most wide-ranging and disruptive changes to recently affect the world’s second-largest medical technology market. Now, with just a two- to four-year transition period before full compliance is required in 2020 for MDR and 2022 for IVDR, device developers will need to implement changes to help new and existing products succeed. The scope and complexity of this legislation will require significant changes in areas such as product development, data reporting, quality assurance and manufacturing processes. While these dates may seem a long way off, manufacturers need to start planning immediately, as adjusting will take time and effort.

The key changes that are occurring under the new regulations
How to prioritize your product portfolio
The importance of early planning in preparing clinical studies to certify new devices and to recertify existing ones
How early transition can give your products an advantage in the market

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Speaker

Karen Hill, BSc (Hons), Senior Manager, Regulatory Affairs, ICON

Karen has over twenty years’ experience in regulatory affairs, clinical studies and research & development in the medical device and in vitro diagnostics (IVD) device industries. She has particular expertise in the regulatory requirements and preparation of design dossiers for CE-marking of EU Class III implantable devices, as well as considerable experience in authoring and reviewing clinical evaluation reports (CERs) for all classes of medical devices across various therapeutic areas. In addition, she has experience of IVD regulations in both the EU and US. Prior to joining the company, Karen was regulatory affairs manager at Vascutek Ltd, a Terumo company and world leader in the design and manufacture of vascular and cardiovascular implants. Prior to joining Vascutek Ltd she was manager of regulatory affairs and clinical studies at Axis Shield Diagnostics Ltd, a manufacturer of innovative IVDs. Karen is a member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and holds a BSc (Hons) in Biochemistry and Pharmacology from University of Strathclyde, Glasgow.

Message Presenter

Who Should Attend?

Senior professionals in the European medical device or IVD industries, including medical device manufacturer personnel from:

Clinical Research
Manufacturing
Quality Assurance
R&D
Regulatory Affairs
Sales/Marketing & Product Management

What You Will Learn

The key changes that are occurring under the new regulations
How to prioritize your product portfolio
The importance of early planning in preparing clinical studies to certify new devices and to recertify existing ones
How early transition can give your products an advantage in the market

Xtalks Partner

ICON

ICON plc is a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organisations. The company specializes in the strategic development, management and analysis of programs that support clinical development. With headquarters in Dublin, Ireland, ICON currently, operates from 97 locations in 38 countries and has approximately 13,380 employees. Further information is available at ICONplc.com.