Mastering EU Medical Device Regulation

Main Photo


Devicemakers face an array of tough new rules as the EU phases in the new Medical Device Directive (MDR) — rules that will change how you do business everywhere in the world.

  • Your entire product portfolio will need re-approval
  • Standards such as the ISO 13485:2016, changed once already, will change again to align with the new MDR
  • Turnaround time for incident reporting will drop from 30 to only 15 days

This barely scratches the surface. The MDR, which replaces the existing Medical Device Directive (MDD), is 175 pages (vs. 60) of new provisions ... changes to existing ones ... inclusions ... and exclusions. And confusion abounds: Rules for accrediting Notified Bodies (NB) aren’t even final yet, for example.

You may think you have lots of time to comply but you don’t: Fewer than two years. Here’s what to do NOW.

Mark your calendar for an intense hands-on training session in Philadelphia, Monday-Wednesday, Sept. 10-12. Over the course of two days understanding and implementing the new MDR ­— plus a third add-on day focusing on post-market activities — you’ll discover:

  • The new MDR classification system: How to apply it
  • Conformity assessment paths: How they apply to specific devices
  • Annex I requirements: How to document compliance
  • Technical documentation requirements in Annex I and Annex II
  • Unique Device Identification: The EU approach
  • Economic operators and their relationship to you
  • Notified Body: What it is, what it does
  • And MUCH more!

Many workshop exercises will be tailored to your specific products. You’ll receive detailed checklists to help classify devices, apply Annex I requirements and conduct internal quality audits, as well as:

  • A map from the MDD Annex I to the MDR Annex I
  • A workbook of device attributes used for UDI implementation

Special Third-Day Add-On:

Post-Market Activities in the EU-MDR: A Detailed Analysis

Add a third day and participate in this all-day workshop untangling one of the most complicated aspects of the new EU-MDR: Post-market activities. You’ll discover:

  • Which devices (by class and other attributes) require any specific activity
  • Developing a plan for each activity
  • Developing a report for each activity
  • Understanding frequency and distribution of each report
  • Adverse events: Understanding classification and reporting
  • And MUCH more!

This add-on workshop assumes a basic familiarity with the EU-MDR. Course I is recommended but not required.

Your workshop leader, Dan O’Leary of Ombu Enterprises LLC, is a favorite of thousands of conference attendees for his ability to simplify the most complex device-related topics.

Philadelphia is a treat in late summer — sunny days, great historical sights, fabulous restaurants and more. Better hurry though — space is limited and reservations are coming in fast. Sign up now.