May 25, 2017
(Originally aired with XTalks)
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 our 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:
- Regulatory compliance
- Authorized representatives
- Quality systems
- Supply chain
- Unique device identifications (UDI)
- EUDAMED database
- Important terminology, transition timelines and expirations related to publications, applications and certificates.
Valynda Machen, CQA, RAC, Principal Medical Research Manager, Regulatory, NAMSA
Valynda Machen, CQA, RAC is a Principal Medical Research Manager at NAMSA. She has over 20 years of medical device experience in the areas of manufacturing, new product development, quality assurance and regulatory affairs, specializing in IVDs. In her current role at NAMSA, she provides regulatory services for clients in many areas including: peripheral vasculature, ophthalmology, IVD, regulatory compliance, quality systems, and UDI.
Prior to NAMSA, she worked for Beckman Coulter where she managed pre- and post-market Regulatory Affairs activities for new and existing IVD products worldwide. Valynda holds a B.S. in Bacteriology from Iowa State University and has obtained certifications in quality auditing and regulatory affairs