Overview

This 2-day virtual workshop 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.

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.

Webinar Takeaway

  • 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

Learning Objectives

  • 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.

Industries who can attend

This 360 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Kelly Thomas


Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  

Faculty Kelly Thomas

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$689

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