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ViewAttendees 22

Solutions Circle

Devices (includes Medical Devices and In Vitro Diagnostics)

Solutions Circle: Annex XVI State of Play

Wednesday, October 4, 2023
12:45 PM – 1:15 PM EDT
Location/Room: Exhibit Hall: Solutions Circles
Intermediate Level
Description: The Common Specifications (CS) were released a month earlier than anticipated in December 2022 with a date of effect in June 2023. Additionally, the European Commission has published the implementing regulation on the reclassification of certain active products that fall under the scope of the Medical Device Regulation (MDR), but which do not have an intended medical purpose (laser/intense pulsed light devices for hair removal or skin treatment, liposuction equipment, and brain stimulation devices).
This session will discuss how NBs are handling these applications and conformity assessments since the publication of the CS and the reclassification act. It will discuss the terms and conditions for the required Annex XVI written agreement (Art. 2.3) and best practices for Annex XVI submissions, including lessons learned and case study examples using specific devices and conformity assessments initiated/completed to date.

Learning Objectives:

  • Understand how NBs are handling these applications following the CSs and Reclassification Act publication.
  • Understand Notified Body expectations for Annex XVI device applications and challenges w/ various devices (examples to be provided)
  • Understand the reclassification act and specifics for applications to be submitted for these devices