Sponsored by:

Complimentary Virtual Conference

July 17, 2019 | 11:00 a.m. - 3:15 pm EDT

EU MDR -
Requirements & Implementation

The EU Medical Device Regulation (EU MDR) require more than a few new SOPs. A profound overhaul of the regulatory approach in one of the world’s largest medical device markets, the EU MDR demands new procedures, evidence development, documentation, relationships, reporting, data management, and a reevaluation of legacy portfolios. Senior management should be involved in strategic planning for changes that can significantly affect a company’s business.


This complimentary, four-hour virtual conference, conducted by leading experts on EU MDR requirements and implementation, provides concise insights into key aspects of the regulation to help companies understand and plan for the impending changes.

Learning Objectives:

During this event, you will learn about:

• EU MDR provisions and timeline
• Strategic considerations and priorities
• The business impact of compliance

• New clinical evidence requirements
• Changes in postmarket surveillance
• Requirements for economic operators
• Supply chain considerations
• Labeling, IFU, and UDI requirements
• Risk management provisions
• Eudamed database reporting requirements
• Remediation of legacy devices

Who Should Attend:

• Senior management
• RA/QA
• Clinical
• Postmarket
• Compliance
• Legal
• Supply Chain
• Global strategy

AGENDA

11:00 am – 11:05 am  Welcome and Introduction
Thomas Maeder – Conference Director, MedTech Intelligence

11:05 am – 11:30 am Implementation Overview
Speaker TBA

• Timeline
• Assessing the magnitude of the changes and the time, effort, and cost of complying with the new requirements
• Notified bodies
• Need for senior management involvement in strategy and planning
• The business impact of EU MDR implementation

11:30 am – 12:15 pm Clinical Evidence and Risk Management Requirements
Speaker TBA

• What clinical evidence is required?
• Summary of Safety and Clinical Performance (SSCP)
• Creating and updating Clinical Evaluation Reports (CER)
• Risk management requirements
• Closer alignment between risk management and clinical evaluations
• Equivalence

12:15 pm – 1:00 pm Postmarket Requirements
Speaker TBA

• Postmarket Clinical Follow-Up Studies (PMCF)
• Periodic Safety Update Reports (PSUR)
• Linkage of postmarket data to other functions – e.g. risk management, clinical, and promotion
• Reporting to Eudamed

1:00 pm – 1:30 pm Suppliers and Economic Operators
Speaker TBA

• Definition of economic operators
• Responsibilities of manufacturers, suppliers, and economic operators
• Need for new contractual agreements

1:30 pm – 2:00 pm UDI and Labeling
Speaker TBA


• New labeling and IFU requirements
• UDI implementation

2:00 pm – 2:30 pm Remediation of Legacy Devices
Speaker TBA


• Performing a gap analysis on the legacy portfolio
• Rationalizing the legacy portfolio – costs and considerations

2:30 pm – 3:15 pm Questions and Answers
All Faculty

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