EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

By: David R. Dills, Director of Regulatory Services at CROMSOURCE.
Product code: SEM63
Location 1: San Diego CA Apr 06 - 07

Description

Course “2 Days Workshop EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete " has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop Tuition per attendee includes the two-day workshop, all workshop materials, Complimentary breakfast and lunch both days provided by WCS"

Schedule for Both Days:

8:00 a.m. – 9:00 a.m.                      Registration and Continental Breakfast

10:30 a.m. – 10:45 a.m.                 Morning Break

12:00 p.m. – 1:00 p.m.                   Lunch Break

2:30 p.m. – 2:45 p.m.                     Afternoon Break

5:00 p.m.                                        Session Wrap-up

With the EU MDR implementation deadline in May of 2020 rapidly approaching, regulatory affairs executives are currently focused on organizing and managing the final steps of the transition to align corporate strategies with new requirements and processes. This seminar will focus on the time remaining in the transition period and what companies can expect from notified bodies and regulators as the implementation deadline draws to a close, as well as clarifying areas of uncertainty such as implementing acts and defining sufficient clinical evidence.

The new EU Medical Devices Regulations (the MDR and IVDR) will be applicable in May 2020 (for medical devices) and May 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are busy preparing the guidance documents and implementing legislation to ensure the Regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. However, there is still much to do, and progress has been slow.

This 2-day interactive seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest changes to the regulations effective and in force for 2020 and will draw out key developments and key dates. The looming EU MDR crisis: Protect your patients.

Areas Covered

• Risk based approach during final implementation transition period
• Threshold of sufficient clinical evidence without equivalency data
• Establishing a relationship and open communication with notified bodies
• Product prioritization based on certification requirements & market viability
• Integrating EUDAMED into workflows without implementation guidance
• The objectives of the MDR, including the significance of replacing directives with a regulation
• Quality management system requirements in the MDR
•Device classification and conformity assessment route changes in the MDR
• Technical documentation requirements in the MDR
• Clinical evaluation process requirements in the MDR
• UDI and traceability requirements in the MDR
• Postmarket surveillance and reporting requirements in the MDR
• Life-cycle review of products linked to risk management and clinical evidence
• Auditing impact of the MDR

Who will Benefit

  • Medical Device Manufacturers and Professionals within Senior Management
  • Regulatory Affairs Managers and Quality Managers
  • R& D specialists, Development
  • Manufacturing and Marketing Managers
  • Internal and External Auditors, Importers
  • Distributors and other medical device professionals in areas of Design
  • Risk Management, and Postmarket activities
  • who work for manufacturers that market and commercialize devices in Europe.

Learning Objectives

  • Describe the objectives and structure of the MDR
  • Identify the key differences between the requirements found in the existing directives and the MDR
  • Explain the impact of the new MDR requirements on economic operators, including manufacturers
  • Describe the different regulatory requirements through life-cycle of device, e.g. premarket, design and development, product realization, and postmarket
  • Identify the necessary steps to prepare an organization to transition to the MDR
  • Plan a gap assessment to transition an organization to compliance
  • Manage concurrent MDD and MDR compliant products, as well as assess the effects of any changes
  • Ensure market continuity for “Legacy” products after May 2020
  • Compile the data required for new technical documentation, submissions and mapping to GSPRs
  • Implement and coordinate post-market data and analysis for proper reporting and trending for mandatory submissions, as well as for compliant QMSs
  • What is the current state of EU MDR – the true and current state?
  • Will you need to spend millions to fulfill clinical data requirements on well-established technologies or legacy devices?
  • What do you need to do if your Notified Body has lost/limited designation?
  • How do you manage the increased cost of hiring, training and development of new resources?
  • What registration and UDI requirements remain in place now that the EUDAMED database launch is delayed to 2022?
  • What are best practices for connecting post market surveillance to design changes and risk management under the new legislation?

 

Bonus: One-on-One and FAQ’s with the instructor to address all of your questions and challenges, review your documentation and address trends for transitioning and MDR Assessments. Walk away with practical solutions to successfully prepare your company for the fast-approaching regulation deadline of May 26, 2020. Q&A with our instructor and with other attendees to get answers to your most pressing questions about MDR

Course Outline:

  •  Risk based approach during final implementation transition period
  • Threshold of sufficient clinical evidence without equivalency data
  • Establishing a relationship and open communication with notified bodies
  • Product prioritization based on certification requirements & market viability
  • Integrating EUDAMED into workflows without implementation guidance
  • The objectives of the MDR, including the significance of replacing directives with a regulation
  • Quality management system requirements in the MDR
  • Device classification and conformity assessment route changes in the MDR
  • Technical documentation requirements in the MDR
  • Clinical evaluation process requirements in the MDR
  • UDI and traceability requirements in the MDR
  • Postmarket surveillance and reporting requirements in the MDR
  • Life-cycle review of products linked to risk management and clinical evidence
  • Auditing impact of the MDR

 

 

speaker

David R. DillsDirector of Regulatory Services at CROMSOURCE

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, among other regulatory and compliance responsibilities. 

06-April-2020 To 07-April-2020 San Diego CA
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