If you sell medical devices globally, changes are looming that will affect your operations greatly.
They’re summed up in the initials EU-MDR, short for European Union Medical Device Regulation, a new set of rules that virtually throws out the existing EU-MDD (Medical Device Directive).
The EU-MDR is 175 pages of eye straining text, you’ll encounter unfamiliar rules and terms… expanded General Safety and Performance Requirements… increased requirements for risk management and post-market surveillance… and much more. We are here to assist you!
You have until May 2020 to comply. Act fast.
Mark your calendar for one, two, three or four productive days of hands-on training with Dan O’Leary of Ombu Enterprises, one of FDAnews’ most in-demand trainers.
Your training kicks off with an introductory 2-day workshop Understanding and Implementing the EU-Medical Device Regulation/In Vitro Diagnostics Regulation on March 17-18. You’ll master the conversion and implement the new MDR including:
- The new MDR classification system (how to apply the system)
- Conformity assessment paths (how paths apply to specific devices)
- Annex I requirements (how to document compliance)
- Technical documentation requirements
- Unique Device Identification (EU approach)
- Notified Body (its role)
Stay an extra day, March 19, to continue your training with Post-Market Activities in the EU-MDR — A Detailed Analysis. Untangle one of the most complicated aspects of the new EU-MDR:
- Which devices (by class and other attributes) require any specific activity
- How to develop a plan and report for each activity
- Understanding frequency and distribution of each report
- Adverse events classification and reporting
Need help with EU-MDR auditing? Extend to March 20 with Implementing Effective EU-MDR/IVDR Internal Audit Programs. Get the information you need to integrate a Notified Body (NB) EU-MDR/IVDR type audit into your internal quality program:
- Conformity assessment paths in the EU-MDR/IVDR based on device class
- Initial NB auditing requirements in each conformity assessment annex
- Surveillance NB auditing requirements
- NB QMS requirements for Annex VII
- Specific Annex VII areas in the initial audit
- NB auditor qualifications from Annex VII
- Mapping the NB audit approach to the medical device auditing program
Space is limited. First come – first served. There’s no time to waste between now and May 2020.