DUBLIN–(BUSINESS WIRE)–The “The New EU Medical Device Regulation” conference has been added to ResearchAndMarkets.com’s offering. Course “The New EU Medical Device regulation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

EU Medical Device 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

Who Should Attend:

• Clinical Trial Managers
• Regulatory Affairs
• Medical Officers

For more information about this conference visit https://www.researchandmarkets.com/research/wmhkzr/new_eu_medical?w=4