EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider

Release Date
May 25, 2017

To listen to the recording of this webinar, please visit the XTalks registration page.

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 2022, to be fully compliant with all changes set forth within the new regulation.

Join NAMSA’s regulatory expert, Valynda Machen, CQA, RAC, Principal Medical Research Manager, Regulatory, for an upcoming webinar  with XTalks 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:

  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:
      •  Regulatory compliance
      •  Authorized representatives
      •  Quality systems
      •  Supply chain
      •  Unique device identifications (UDI)
      •  EUDAMED database

5.Important terminology, transition timelines and expirations related to publications, applications and certificates.

To listen to the recording of this webinar, please visit the XTalks registration page.