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.
04/09/2018 10:00 AM04/09/2018 04:00 PMTraining Topic: The New EU Medical Device RegulationInstructor: Salma Michor
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.
Review of the structure of the new regulation
Overview of impact areas of regulatory change
Clinical data PMS and PMCF/clinical evaluation reports
Technical documentation requirements
Unique device identification
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).
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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.