Regulation proposals of the European Commission Background
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.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 Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.
Why you should attend:
Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.
Areas Covered in the Session:
- The updated Regulation
- Implementation dates and transition
- Main changes and products affected
- Effect on medical device manufacturers
Speaker
Salma Michor
PhD, MSc, MBA, CMgr, RAC
Salma
Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving
such clients as Johnson & Johnson, Novartis, Shire, Pfizer and
Colgate Palmolive. Previously, Michor 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.
Please fill in your name and email to receive the seminar agenda of this event.
Time: 9:00 AM to 6:00 PM
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
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Who will benefit:
- Clinical Trial Managers
- Regulatory Affairs
- Medical Officers
Venue
Venue to be confirmedHouston, TX