Devicemakers, be warned: The EU has up-ended its rules.
Are YOU ready for this?
Manufacturers of IVDs and other medical devices face major changes in international regulation. The EU has replaced the current three directives with two new regulations that are much tougher and promise to transform the way you do business abroad.
The regulations bristle with new provisions, inclusions, exclusions, and changes. One regulation covers in vitro diagnostic devices while one covers all other devices, including active implantable devices.
Did you know:
- Your entire product portfolio will need to be re-approved
- But the rules for accrediting Notified Bodies (NB) aren’t even final yet
- The regulations will change the classification of some devices while providing a new system for IVDs
- Standards just released, such as the ISO 13485:2016, will change to align with the new regulations
And this barely scratches the surface.
In light of the urgency of these changes, FDAnews has teamed up with Ombu Enterprises Inc. to present a two-day workshop that brings you current with all the new rules and readies you to comply ... before the MDR and IVDR takes effect.
By the time you head for home, you will:
- Understand the new provisions of the MDR & IVDR
- Recognize the changes from existing practices
- Formulate an implementation project tailored to your own organization, products, and needs
- Discover how to satisfy the requirements of the new regulations
Because the EU developed the new regulations in parallel, many provisions of the MDR and IVDR are the same. The workshop covers these similarities while explaining the differences.
A special feature of this workshop: The opportunity to apply the MDR’s new provisions to one of your own products that currently has the CE Mark under the MDD (especially Annex II) and satisfies the U.S. UDI rule. You’ll apply many of a series of 13 hands-on exercises to the product you bring. The exercises include section tailored to the appropriate provisions of the MDR and the IVDR.
Here are highlights of what you’ll cover in two days of learning-by-doing:
- Role of medical device regulations in the EU system
- The MDR medical device classification system and how to apply it
- The IVDR classification system and how to apply it
- The conformity assessment paths as they apply to particular devices
- The Annex I requirements and how to document compliance
- Technical documentation requirements in Annex II and Annex III
- The quality management, risk management and post-market surveillance systems: Their requirements and connections
- Vigilance, trend reporting, and field safety corrective actions
- The EU approach to Unique Device Identification (UDI)
- The concept of economic operators — relationship to manufacturers, role and qualifications of persons responsible for regulatory compliance
- The Notified Body and its role
- And much more!
Workshop leader Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops, boasts 30+ years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices, and clinical labs. His consultancy, Ombu Enterprises LLC, focuses on operational excellence and regulatory compliance particularly for small manufacturing companies. He 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.
With Boston’s deep connections to American history plus world-class attractions and restaurants, you’ll want to tack on a few extra days for a strolling visit ... or a Cape Cod getaway.
You must master the new MDR if you intend to continue selling medical devices in the EU. This two-day workshop gives you the tools you need. It’s a must-attend.
Description of the Exercises
Exercise A1 – QMS and RMS Analysis
This exercise matches selected sections from ISO 13485:2016 and ISO 14971:2007 to the corresponding requirement in the Medical Device Regulation to determine if the international standard would fulfill the MDR Requirement.
Exercise B1 – Person Responsible for Regulatory Compliance
This exercise analyzes the requirements to be a person responsible to allow each participant to determine if they could fill the role.
Exercise B2 – Economic Operators
This exercise provides an opportunity to classify economic operators in the EU-MDR, EN ISO 13485:2016, and US FDA frameworks
Exercise C1 – Elements of the QMS
This exercise identifies required elements in the Quality Management System, QMS, and helps participants determine any additional work needed to satisfy the new regulations
Exercise D1 – Elements of the RMS
This exercise identifies required elements in the Risk Management System, RMS, and helps participants determine any additional work needed to satisfy the new regulations
Exercise E1 – Elements of the PMSS
This exercise identifies required elements in the Post-market Surveillance System, PMSS, and helps participants determine any additional work needed to satisfy the new regulations
Exercise F1 – Unique Device Identification
This exercise analyzes a device that satisfies the US UDI system to determine any additional work needed to satisfy the EU-MDR system. Participants are encouraged to bring UDI information for a device their company markets.
Exercise G1 – Device Classification
This exercise uses some example devices to provide an opportunity to apply the EU-MDR or the EU-IVDR classification rules. Participants are encouraged to bring classification information for a product their company markets with the CE Mark.
Exercise H1 – Conformity Assessment
This exercise provides participants an opportunity to apply the conformity assessment requirements in the EU-MDR or EU-IVDR to an example product. Participants are encouraged to bring information for a product their company markets with the CE Mark.
Exercise I1 – General Safety and Performance Requirements
This exercise gives participants an opportunity to understand how some of the EU-MDR and EU-IVDR requirements differ from the corresponding requirements in the directives. Participants are encouraged to bring information for a product their company markets with the CE Mark.
Exercise J1 – Technical Documentation in Annex II
This exercise provides participants with an opportunity to understand the structure of the documentation required in Annex II Technical Documentation
Exercise J2 – Technical Documentation in Annex III
This exercise provides participants with an opportunity to understand the structure of the documentation required in Annex Technical Documentation on Post-market Surveillance
Exercise K1 – Declaration of Conformity
This exercise provides participants an opportunity to identify the required elements of a Declaration of Conformity. Participants are encouraged to bring information for a device their company markets with the CE Mark.
Course Binder Materials:
- Slides from PowerPoint presentations
- Interactive exercise worksheets
- Additional reseource materials