Facts – Until You Reach Your the New EU Medical Device Regulation

Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

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.

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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 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.

-> Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

  • Clinical Trial Managers
  • Regulatory Affairs
  • Medical Officers
  • The updated Regulation
  • Implementation Dates and Transition
  • Main changes and Products Affected
  • Effect on Medical Device Manufacturers

New EU Medical Device Regulation

Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies

Posted 11 September 2017 By Zachary Brennan

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FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective.

Opening with a discussion of the ways in which the gap of time between the discovery of the science behind new treatments and the adoption of such treatments has been shrinking, Gottlieb outlined a few of the ways in which the agency is modernizing its approach to collecting and evaluating clinical information.

And on a day when the discussion of how much it costs to develop a new oncology drug is being hotly debated with the release of a new study, Gottlieb also discussed how the costs of drug development “are also high, and growing.

“There’s been criticism of the various estimates of how much it costs to develop a new drug,” he said, according to the transcript of his speech. “Moreover, on a relative basis, in many cases the costs of early stage drug development has grown at a proportionally faster rate than the cost of late stage drug development. In other words, inflation in early stage drug trials is rising faster than inflation in late stage development.

“By front-loading the cost of drug discovery, the broader biomedical community is making it harder to advance new ideas. It’s economically harder to capitalize the cost of an early stage drug program, relative to funding a later stage project. So frontloading the costs are a recipe for reducing the amount of new ideas that can be advanced.”

 

Read More information: http://snip.ly/6ude0#http://www.raps.org/Regulatory-Focus/News/2017/09/11/28442/Gottlieb-Targets-Drug-Development-Costs-Clinical-Development-Efficiencies/

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