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EU-Medical Device Regulation and In Vitro Diagnostics Regulation Compliance

Presented by FDAnews and Ombu Enterprises

Medical device regulations in the EU are changing and changing fast. If your business is global, you can’t avoid these crucial adjustments.

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Save 15% with promo code EUMDR15 when you order the virtual workshop series and the Devicemaker’s Guide to EU-MDR: 71 Worksheets for Manufacturing Compliance by Nov. 10.

The EU-MDR and EU-IVDR have significantly more requirements than the EU-MDD, pushing forward a series of detailed guidelines. The EU-MDR includes expectations around unique device identification, economic operators, and the requirement that there be a person responsible for regulatory compliance. It covers expanded, extensive general safety and performance requirements under Annex I. The requirements for risk management, post-market surveillance, and technical documentation have also grown under these regulations.

With one extension already granted, any organization selling devices in the region now need to be ready for the shift by May 2021. There’s little time to spare to get your processes up to par — but FDAnews can help get you there.

And if you haven’t aligned your manufacturing with these expectations yet, there is still hope. It may be impossible to fully meet the EU-MDR or EU-IVDR, but we can show you how to remain compliant under Article 120 or Article 110 while you transition into the regulatory requirements.

This virtual workshop series has the expert answers and practical knowledge you’ll need to move your programming forward in a way that meets these new regulations. The documents are complicated and technical, covering both company-level requirements and device-level expectations and the workshop series, which runs over four days, will cut to the most important portions and guide you with the tips and insights you need.

When you join us, you’ll hear from a regulatory expert, receive detailed checklists on device classifications, the application of Annex I and internal quality audits and gain a workbook on UDI implementation.

Mark your calendar for one, two, three, or four productive, exciting days of hands-on learning with Dan O’Leary, a renowned regulatory and training specialist.

Session 1

EU-MDR Implementation

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Session 2

IVDR Implementation

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Session 3

Market Activities for the EU-MDR and EU-IVDR

View Agenda

Nov. 10, 2020

Auditing EU-MDR and EU-IVDR Implementation

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In our fourth and final session, we’ll discuss Auditing EU-MDR and EU-IVDR Implementation on Tuesday, Nov. 10. We’ll share insights on the importance of good project management methods, including those around:

  • Internal Audit Programming: ISO 19011:2018 and 13485:2016
  • Conformity Assessment Paths and Device-Specific Areas: QMS and RMS; Annex I, II, and III
  • Applications to Notifying Bodies
  • Notifying Body Approach to Audits

It’s not too late to view the first, second and third sessions which took place on Sept. 29, Oct. 17 and Nov. 4. They’re available in the workshop recording archive.

In the first session — EU-MDR Implementation — you have the opportunity to dig deep into EU-MDR requirements and how your team can move toward full implementation. We covered:

  • Article 120: Transitioning into the EU-MDR through timeline concerns
  • QMS Implementation: Article 10(9) requirements and other QMS elements
  • Device Implementation: Annexes I, II, III, VIII and Article 52
  • Notified Body Interactions: Conformity assessment, notified body technical document review, and notified body on-site audits

During the second session we discussed EU-IVDR Implementation. While the date for these requirements isn’t until May 2022, the time to get started on these changes is now. We covered:

  • Article 110: Transitioning into the EU-IVDR through timeline concerns
  • QMS Implementation: Article 10(8) requirements and QMS elements
  • Device Implementation: Annex I, II, III, VIII and Article 48
  • Notified Body Interactions: Conformity assessment, notified body technical document review, and notified body on-site audits

During the third session on Post-Market Activities for the EU-MDR and EU-IVDR we discussed:

  • Pre-Market Considerations: Clinical evaluation and performance, risk management and determination, and pre-market indicators and thresholds
  • Market Surveillance: Market and post-market surveillance; clinical follow-up
  • Post-Market Performance Follow-Up and SSCP
  • Vigilance and Trend Analysis

The deadlines for these new regulations are approaching quickly. Don’t miss this chance to gain expert advice on what can become a complicated, difficult, and long process—and do it all from the comfort of your own home.

Reserve your spot at this critical workshop today.

Who Will Benefit

  • Regulatory compliance personnel
  • Quality managers and directors
  • Quality engineers
  • Risk management specialists
  • Regulatory managers
  • Design engineering managers
  • Supply chain managers focused on procurement and distribution
  • Production managers and engineers
  • Document control specialists
  • Marketing managers
  • Clinical managers
  • Clinical evaluation specialists
  • Export compliance managers

Meet Your Presenter

Dan O

Dan O'Leary


Ombu Enterprises LLC

Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is now President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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