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6-Hour Virtual Seminar – The New EU Medical Device Regulation

July 11 @ 8:00 am - 2:00 pm CDT

$545.00

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

https://www.globalcompliancepanel.com/virtual-seminar/-11469LIVE?corporatecomplianceinsights-SEO

Details

Date:
July 11
Time:
8:00 am - 2:00 pm CDT
Cost:
$545.00
Website:
https://www.globalcompliancepanel.com/virtual-seminar/-11469LIVE?corporatecomplianceinsights-SEO

Organizer

24528

Venue

28706