Day 1

  • Overview of the EU-MDR, focusing specifically on key changes
  • How to plan and scope your EU-MDR transition program
  • How to conduct a thorough gap analysis specific to EU-MDR transition
  • How to scale your transition program to encompass the entire operation
  • The key steps of implementing an EU-MDR transition program
  • Timeline consideration
  • Review new EU-MDR Requirements impacting Post Market Surveillance:
  • Discuss Post-Market Surveillance plans and what data should be included in the Technical Documentation

Day 2

  • Discuss proactive and systematic approaches to collecting and assessing information
  • Review suitable indicators for benefit-risk analysis
  • Review how to proper investigate complaints
  • Discuss methods for trend reports
  • Discuss methods and protocols to communicate effectively with Competent Authorities (CAs), Notified Bodies, users
  • Periodic Safety Update Report (PSUR)
  • Discuss effective tools to trace and identify devices for which corrective actions are necessary
  • Discuss Post-market Clinical Follow-up (PMCF) plan

Seminar Objectives:

  1. Understand the regulatory requirements EU-MDR and the impact on Post Market Surveillance
  2. Understand how to apply those requirements
  3. Explain the new regulatory expectations regarding Risk Management
  4. Understand the consequences of non-compliance

About The Course:

About Faculty: KELLY THOMAS

This 2-day virtual 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 and will draw out key developments and key dates. The looming EU MDR crisis: Protect your patients.

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) for medical devices and 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.

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.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

Who Should Attend:

Those who work for manufacturers that market and commercialize devices in Europe including:
- 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 Post-market activities

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