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.
Who Will Benefit
- Clinical Trial Managers
- Regulatory Affairs
- Medical Officers
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, 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.
Time: 08:00 AM PST | 11:00 AM EST- The updated Regulation
- Implementation dates and transition
- Main changes and products affected
- Effect on medical device manufacturers