The New EU Medical Device Regulation

Overview:

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

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

Who Will Benefit:

• Clinical Trial Managers
• Regulatory Affairs
• Medical Officers