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Date/Time
Date(s) - 05/09/2019
8:30 am - 4:30 pm CEST

Location
Hotel Movenpick Hotel Stuttgart Airport & Messe

Categories

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.

Description:
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.

Learning Objectives:

  • 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

Pricing:

Early Registration through 14 April, 2019: $394.50 US (350€)
Regular Registration beginning 15 April, 2019: $507.00 US (450€)

Accommodation:

NAMSA has secured a limited number of sleeping rooms for attendees at the nightly rate of 348€ . To book, please call +49 711 553440 directly and reference “NAMSA” to secure your rate.

Event Details

Ticket Type Price Spaces
Registration $ 507.00

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8:30–9:00 Check-In
9:00–10:00 Overview
  • Current Status of MDR
  • EN ISO13485:2016
10:00–11:00 What Manufacturers Need to be Doing Now
  • Notified Body Relationship
  • Impact assessment of the MDR
 
11:00–11:15 Break
11:15–12:00 What Manufacturers Need to be Doing Now, Continued
  • Gap analysis of clinical data
  • Gap analysis against GSPRs
12:00–1:00 Lunch
1:00–14:45 What Manufacturers Need to be Doing Next
  • Revision of QMS
  • Review technical documentation against Annex II and II
  • Economic Operators
  • Person responsible for regulatory compliance
14:45–15:15 Break
15:15–15:30 Future After 2020
15:30–16:30 Workshop
Adrian Keene, is Director of Product Development Strategy at NAMSA, where he 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.