SOURCE: Xtalks

Xtalks Webinars

May 10, 2017 07:30 ET

EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider, New Webinar Hosted by Xtalks

Industry expert Valynda Machen, Principal Medical Research Manager, Regulatory at NAMSA will help the audience to better understand the significant changes that IVD manufacturers should prepare for now to be successful under the new regulation

TORONTO, ON--(Marketwired - May 10, 2017) - The current EU IVD Directive (98/79/EC) has existed in Europe since 1998. However, because 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.

Discussion points will include:

  1. The move to risk-based classification from the previous list-based classification method, including information on classification rules, definitions and conformity assessment pathways.
  2. New technical file requirements comprised of clinical evidence requirements such as essential safety and performance requirements, common specifications and declaration of conformity changes.
  3. 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).
  4. Updated roles and responsibilities that will be required for successful implementation of the new regulations related to:
  1. Regulatory compliance
  2. Authorized representatives
  3. Quality systems
  4. Supply chain
  5. Unique device identifications (UDI)
  6. EUDAMED database
  1. Important terminology, transition timelines and expirations related to publications, applications and certificates.

Join Valynda Machen on Thursday, May 25, 2017 at 10am EDT (3pm BST/UK). For more information or to register for this complimentary event, visit: EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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