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EU Medical Device Regulation

Your one stop shop for EU MDR implementation advice

Highlights Include:

Managing the transition to the EU MDR and beyond…
  • Competent Authority and Notified Body feedback on implementation
  • Notified Body designation: Scope, resource and timelines – what are the unknown unknowns?
  • Economic Operators: Creating a structure to avoid duplication and ensure compliance
  • Global convergence of regulatory requirements: Challenges, opportunities and looking to the future
Competent Authority and Notified Body perspectives from:
  • MHRA (Invited)
  • DKMA
  • BMG (Federal Ministry of Health – Germany)
  • TÜV SÜD Product Service
  • BSI
  • SGS
Get answers to the questions keeping you awake at night
  • How can you engage stakeholders to ensure MDR readiness?
  • Will your Notified Body have the scope?
  • Beyond March 2019: Brexit and the MDR – what does it mean for implementation and industry's relationship with Competent Authorities?

On-Demand EU MDR Content

EU MDR Webinars

EU Medical Device Regulations, NB overview and update from BSI

James Newman, Technical Specialist, Scheme Manager & Training Lead – General Devices, BSI Group

EU MDR: Latest updates and practical experiences on implementation

Caroline Byrd, Director Regulatory Affairs, Abbott

Why start now: A practical approach to kick-starting your MDR/ IVDR implementation

Jay Crowley, VP and Practice Lead – UDI Services and Solutions, USDM Life Sciences