EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider
Date: Thursday, May 25, 2017
Time: 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
Duration: 60 minutes
- Valynda Machen, CQA, RAC, Principal Medical Research Manager, Regulatory, NAMSA
The current EU IVD Directive (98/79/EC) has existed in Europe since 1998. However, as a result of continued scientific and technological advancements, this Directive is no longer 'fit for purpose.' Over time, there have been significant deviations from the Directive, forcing a departure from the document's original objectives and goals of maintaining the health and safety of IVD devices. The new In vitro Diagnostic Regulation (IVDR) was officially passed by the EU Parliament on April 4, 2017, which includes changes to strengthen the effect of legislation and better address IVD safety. IVDR device manufacturers now have five years, until 2021, to be fully compliant with all changes set forth within the new regulation.
Join NAMSA’s regulatory experts for this upcoming webinar to better understand the significant changes that IVD manufacturers should prepare for now in order to be successful under the new regulation.
Discussion points will include:
- The move to risk-based classification from the previous list-based classification method, including information on classification rules, definitions and conformity assessment pathways.
- New technical file requirements comprised of clinical evidence requirements such as essential safety and performance requirements, common specifications and declaration of conformity changes.
- Potential impacts to your Notified Body (NB), including new accreditation and classification requirements, and the projected, increased workload of 80 – 90 percent NB involvement with IVD assessments (vs. today’s average of 10 – 20 percent).
- Updated roles and responsibilities that will be required for successful implementation of the new regulations related to:
a. Regulatory compliance
b. Authorized representatives
c. Quality systems
d. Supply chain
e. Unique device identifications (UDI)
f. EUDAMED database
- Important terminology, transition timelines and expirations related to publications, applications and certificates.
Keywords: Medical Device, IVD
Valynda Machen, CQA, RAC, Principal Medical Research Manager, Regulatory, NAMSA
Valynda Machen (CQA, RAC-US) has over 20 years of medical device experience in the areas of In Vitro Diagnostic (IVD) manufacturing, new product development, quality assurance and regulatory affairs. She holds a B.S. in Bacteriology from Iowa State University and obtained certifications in quality auditing and regulatory affairs. Valynda is currently a Senior Medical Research Manager for NAMSA.
|THIS PROGRAM IS INTENDED FOR|
- Clinical Trial Teams
- Clinical Operations
- Clinical Project Management
- Monitoring Managers
- Clinical Management
- Procurement Teams
- Heads of R&D
- Regulatory Affairs
- Outsourcing Executives
- Sponsor and CRO Employees
|OUR XTALKS PARTNER FOR THIS EVENT|
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA's MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move client's products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.