Date(s) - 09/19/2019
8:30 am - 4:30 pm EDT
The EU’s new Medical Device Regulation (MDR), which entered into force on 26 May 2017, builds on the framework of the existing Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMD). Now is a critical time for manufacturers as they prepare for conformity by the mandatory compliance date of 26 May 2020.
The MDR brings multiple challenges for global medical device manufacturers, including limited time to understand and implement the requirements for CE certification and business continuity. With the continued lack of guidance and interpretive documents from key stakeholders, manufacturers must make progress with their best interpretations of current expectations.
This one-day workshop, prepared by experts who have previously worked for leading EU Notified Bodies, will provide in-depth information for medical device professionals who have a basic knowledge of the CE Mark process under the existing MDD and AIMD regulations.
- Relate the changes in the MDR to company planning, priorities and portfolio
- Consider current guidance and areas of uncertainty, with recommendations for best practice approaches
- Review strategies for maintaining CE certification using the existing directives under transitional provisions
- Demonstrate how relationships with supply chain partners will change
- Identify problems that may arise with specific devices, company quality systems and resources
- Develop and assess progress against the transition plan for implementing changes
Who Should Attend?
- Medical Device Executives and CEOs
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management
- Medical Device OEM and Suppliers
- EU Authorized Representatives
- EU Medical Device Importers and Distributors
Early Registration through August 31, 2019: $450.00
Regular Registration beginning September 1, 2019: $675.00
Reservations are closed for this event.
|8:30 - 9:00 am||Check-in|
|9:00 - 11:00 am||
|11:00 - 11:15 am||Break|
|11:15 - 12:00 pm||EU Implementation Model Cont'd|
|12:00 - 12:45 pm||Lunch|
|12:45 - 2:45 pm||EU Implementation Model Cont'd|
|2:45 - 3:00 pm||Break|
|3:00 - 4:30 pm||
|Adrian Keene, Director of Product Development Strategy and Manager, EMEA Regulatory and Quality Services at NAMSA, utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He has worked with a broad range of devices, including drug-device combination products. Adrian was previously the Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In total, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.|