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Boston Professional Events List
Live Webinar Understanding and Applying the New EU Medical Device Regulations (EMDR)
Link to Website
Ticket Price: $179 One Dial-in One Attendee | Corporate Live Recorded $279 One Dial In - Max 10 attendees |Group $695 Multiple locations upto 5 dial in | Recorded $249
Why Should you Attend
• Device manufacturers looking to abide by the EU's new medical device and in vitro diagnostic regulations take note: The EU's overhaul of its framework is here
• Scope & Plan, GAP assessment, Portfolio analysis, Global Impact Assessment are just some of the steps on the road to MDR implementation that must be addressed to ensure compliance
• All notified bodies will need to reapply for certification
• The EU’s medical devices database, Eudamed, will now contain UDI data, single registration numbers for all economic operators, accreditation and designation data for notified bodies, and more
• Device makers will have to appoint a specific person to take responsibility for regulatory compliance
• Turn-around time for reporting adverse events will drop from 30 days to only 15 days
• The EU standard EN ISO 13485, recently updated to incorporate changes made in 2016, will likely have to be revised again
• Update you on the current state of the legislation — What does the recent political agreement mean?
• Highlight the areas of greatest risk and opportunity
• Provide models for how companies can assess their readiness and prepare
• Outline a clear path to compliance
• Much more...
Objectives Of the Seminar
• The new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) present the first major changes to the EU medical device regulatory environment in more than 20 years.
• The two new regulations will replace the three existing Medical Device Directives
• The MDR will impact ALL device manufacturers
• Major changes to clinical evidence requirements
• Own Brand Labeler (OBL)" manufacturers will practically be made history-All OBL devices will need to have full Technical Files (art. 8.2, art. 8.4), as well as clinical data (art. 8.2).
• Major labeling changes: Unique Device Identification (UDI) codes must be included on all medical device labels; other significant changes to labeling requirements in the MDR will also need to be addressed
• Tighter control over distribution chains
• MDR scope is expanded to include new product lines
• Changed role for Notified Bodies
• Authorized Representatives’ liability increases
• UDI requirements in the MDR and IVDR
• Differences between US UDI requirements and the MDR and IVDR requirements
• Status of the implementation and EUDAMED systems
• Solutions, processes and best practices we see in the industry as companies begin to understand and prepare for MDR and IVDR and other UDI initiatives
• Live Q&A and interactive session
• In terms of implications for CE Marking, certificates issued prior to final implementation of the MDR in late 2019 or early 2020 will have a maximum validity of five years
• All CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force
• The EU has up-ended its entire medical device oversight system — replacing its three current guidance directives with two massive regulations that bind device makers to a variety of new requirements
Who will Benefit
• Clinical Operations
• Regulatory Affairs Management
• Quality Assurance Management
• Manufacturing Operations/Supply Chain
• Regulatory Affairs Specialists/SME’s
• UDI Specialists/SME’s
David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts regulatory and compliance assessments.
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