CE Marking of Aesthetic (Annex XVI) Devices under the MDR

Online Seminar
CE Marking of aesthetic (Annex XVI) devices under the MDR
Tuesday, September 19th, 2023 |  09:00-12:00 | On ZOOM

Hot topics:

• Understanding the Common specifications for Annex XVI devices
• Requirements for testing
• Risk Management and Clinical Evaluation process

Featuring guest speakers from an accredited test laboratory and Physio-Logic MDR task force.

Moderated by Yael Goldbrener, VP Q&R Services, Medical Device Practice, Physio-Logic.

About the seminar

A learning opportunity that is aimed to familiarize manufacturers of Devices without an intended medical purpose with the requirements of the EU MDR.

Key topics

• What are Annex XVI devices?
• What are the requirements set forth in the Common Specifications 2022/2346, 2022/2347, 2023/1194
• Requirements for testing- Safety and EMC for medical devices
• Clinical Evaluations of devices without a medical purpose
  Target audience:amitpexpor

Manufacturers of Aesthetic Products or Products with a Non-Medical Purpose. 

Agenda:  

09:00-09:05  Welcome

Daphna Sternfeld, Deputy CEO, Head of Export College, IEI 

09:05-09:35  What are Annex XVI devices?

Yael Goldbrener, VP Q&R Services, Physio-Logic

09:35-10:15  The new Common Specification requirements for Risk Management and Labelling

Yael Goldbrener, VP Q&R Services, Physio-Logic

10:15-10:30  Break

10:30-11:00  Requirements for testing- Safety and EMC for medical devices

Anthony Nikitin, Medical Device Compliance Team Leader, Carmel Laboratories

11:00-11:45  Clinical Evaluations of devices without a medical purpose

Gadi Ginot, CEO, Physio-Logic

11:45-12:00  Q&A and summary

Yael Goldbrener

About the speakers:

Gadi Ginot, CEO, Physio-Logic. Internationally renowned expert, and popular guest speaker. Gadi brings forward over 30 years’ experience in accelerating the approval and certification of innovative medical devices worldwide with a scorecard of supporting hundreds of submissions, certifications, and clinical trials.

Yael Goldbrener, VP Q&R Services, Physio-logic

Over 20 years' experience in the medical device industry in the capacity of QA & RA Manager. Track record of medical device regulatory submissions, including 510(k), CE Marking and AMAR. Currently leading companies to ISO13485:2016, EU MDR (regulation 2017/745) and MDSAP, preparations for FDA inspections, developing regulatory strategies and more.

Anthony Nikitin, Medical Device Compliance Team Leader, Carmel Laboratories

Experienced in various compliance disciplines with a specialty in Medical Device compliance and global access.