The New EU Medical Device Regulation

Duration: 60 Minutes
flat 40% off on this webinar use promo code
In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.
New EU Medical Device Regulation
Instructor: Salma Michor
Product ID: 509204
The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This webinar will look at what to expect when the new regulation is implemented.

Objectives of the Presentation
  • The Updated Regulation
  • Implementation Dates and Transition
  • Main Changes and Products Affected
  • Effect on Medical Device Manufacturers
Why Should you Attend
As a medical device manufacturer, importer or distributor it will be critical to have a good understanding of the new regulations, the scope and full impact on the business. Many companies will have combination products and so both the changing pharmaceutical and medical devices regulations are relevant. And the current Directive will be significantly altered and replaced by a regulation which is legally binding on all member states. Attend this training to understand new regulation.

Areas Covered
  • Review of the structure of the new regulation
  • Overview of impact areas of regulatory change
  • Product Classification
  • Clinical data PMS and PMCF/clinical evaluation reports
  • Transition arrangements
  • Technical documentation requirements
  • Unique device identification
  • Economic operators
  • Technical data including risk management
Who will Benefit
Top management; Regulatory management; Quality Management; Sales and Marketing Management; Quality Engineers; Personnel involved in development and implementation of the QMS; Clinical research and medical operations; Project Managers; Product Development personnel; Manufacturing personnel; Researchers managing Medical Device R&D and Development; Quality Assurance such as GMP, GCP Auditors; Clinical trial supply personnel; CRO personnel; All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (25 expanded countries).
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously,She worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.
View More