The new European medical device regulation imposes a broad array of stringent new requirements on medical device manufacturers. This program takes a high-level approach to the business strategy and organizational challenges of evaluating a company’s portfolio of legacy and pipeline products to determine the impact of the new regulation, perform a gap analysis, calculate the profit and cost of remediation, establish a timed and stratified approach, and to modify or create those internal structures needed to bring current products into compliance and to efficiently maintain compliance in the future. In this highly interactive workshop, companies and notified bodies share strategies and procedures for approaching these massive changes.

Topic Outline

The Challenge

  • MDD vs MDR key differences
  • Timelines and deadlines
  • Major areas requiring organizational changes and significant costs

Impact of New Clinical Requirements

  • Clinical Evaluation Reports (CER)
  • Summary of Safety and Clinical Performance (SSCP)
  • Creating or updating the risk file and building a closer alignment with clinical
  • Gap analysis between typical legacy product evidence and new requirements

Impact of Postmarket Requirements

  • Postmarket surveillance requirements and deadlines
  • Postmarket Clinical Follow-Up Studies (PMCF)
  • Periodic Safety Update Reports (PSUR)
  • More robust links between postmarket data and other quality functions
  • Gap analysis between existing procedures and new requirements

Rationalizing the Legacy Portfolio

  • Inventory and analysis of the legacy portfolio
  • Upclassification and other changes
  • New documentation and conformity assessments
  • Factors to consider in rationalizing the portfolio
  • The cost of remediation

Impact of New Equivalence Requirements

  • Review of prior use of equivalence
  • Practical and financial costs of proving equivalence for legacy products
  • Applying clinical evidence requirements under MDR – impact to legacy arguments

Impact of New Rules on Economic Operators & Supply Chain

  • Reevaluation of suppliers and supplier selection criteria
  • New contractual agreements with economic operators
  • Meeting traceability requirements
  • Gap analysis between typical legacy product procedures and new requirements

Impact of Labeling & IFU Requirements

  • Labeling revisions
  • Translations
  • Instructions for use
  • Use of web sites
  • New requirements for hazardous substances
  • Gap analysis between typical legacy product procedures and new requirements

Impact of UDI & Eudamed

  • Implementing UDI
  • Reporting and updating data to Eudamed
  • Gap analysis between typical legacy product procedures and new requirements
  • General Data Protection Regulation (GDPR)

Organizational Impacts

  • Resource modeling for fulfilling postmarket requirements
  • Impact of new workflows and deliverables on organizational structure, training and size
  • Impacts to relationships and interactions with Notified Bodies, HCPs, suppliers, and economic operators
  • Training on new requirements and procedures

Business Strategy

  • Structuring the remediation and compliance project – creating an enterprise-wide, cross-functional approach overseen at the senior management level
  • Determining internal and external resource requirements
  • Budgeting – translating required remediation activities into costs and timelines
  • Evaluating the legacy product portfolio and staging compliance activities

EU IVDR Implementation

April 11 - 12, 2019
Washington, DC & Virtual

Learn More

EU MDR the Cost of Compliance: Assessing Infrastructure and Resource Impact

May 20 – 21, 2019
Washington, DC & Virtual

Learn More

MedTech Import/Export Regulations, Procedures, Best Practices

April 15 – 16, 2019
Washington, DC & Virtual

Learn More

EU MDR Clinical & Postmarket Surveillance Strategies

May 21 – 22, 2019
Washington, DC & Virtual

Learn More

EU MDR Supply Chain & Economic Operators

April 16 - 17, 2019
Washington, DC & Virtual

Learn More

EU MDR Labeling, IFU, UDI, & Eudamed

May 23 - 24, 2019
Washington, DC & Virtual

Learn More

Pricing

We offer Team, Enterprise and multi-conference Discounts.
Veronica Allen, Conference Manager can help you select the right discount plan for you and your organization.

Register Today!

Day(s)

:

Hour(s)

:

Minute(s)

:

Second(s)

css.php