UDI in the EU – A Preliminary Look

Speaker

Instructor: Daniel O Leary
Product ID: 704854

Location
  • Duration: 90 Min
Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.
RECORDED TRAINING
Last Recorded Date: May-2017

 

$279.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$379.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

Bonus Material:

Participants will receive a PDF of the summary of UDI requirements in both the MDR and the IVDR.

Why Should You Attend:

The EU has made available the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) before the final versions come into effect. These regulations describe the EU approach for Unique Device Identification. The regulations raise many interesting issues as part of the implementation. For example, the regulations include the distribution chain in UDI. An Economic Operator includes the manufacturer, the importer and the distributor. Importers and distributors verify the manufacturer assigned a UDI. For some kinds of devices, the Economic Operator as well as Health Institutions must keep records of the UDIs they have supplied or received.

Production Identifiers identify the unit of device production and could include serial number, lot/batch number, Software identification, manufacturing date or expiration date. If the label has a lot number, serial number, software identification or an expiration date on the label, then it becomes part of UDI-PI. The manufacturing date does not have to be part of UDI-PI unless it is the only production identifier on the label.

The regulation has special consideration for specific device types such as implantable devices, procedure packs, configurable devices and software.

There is a database with twenty-two core data elements including device status (not placed on the market, recalled, Field Safety Corrective Action initiated), name and address of the manufacturer and if applicable, the authorized representative and the device risk class. The database structure and submissions methods are not yet available.

Areas Covered in the Webinar:

  • Describe the role of UDI in the MDR and IVDR
  • Explain the concept of an Economic Operator and the relationship to the UDI system
  • Describe the label device label requirements associated with UDI
  • Explain the EU database core elements
  • Identify the requirements for specific device types
  • Explain the ISO 13485:2016 requirements for UDI and how they might apply in the EU

Who Will Benefit:

  • Regulatory Managers
  • Design Engineers
  • Product Managers
  • Labeling Specialists
  • Project Managers
  • Quality Managers
  • Quality Engineers
Instructor Profile:
Daniel O Leary

Daniel O Leary
President, Ombu Enterprises, LLC

Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. 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.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method