European Medical devices Guidelines

My Experience With Differences in FDA & EU Medical Device

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Medical devices - the European framework

The EU sets the regulatory framework for the safety of medical products in the European Economic Area by policy.

The following guidelines should always be considered in conjunction with the national regulations, as many exceptions exist.

EU Regulatory Framework

The EU's involvement Concerns Mainly the regulatory framework for market access, international trade relations and regulatory convergence, all aiming to Ensure the highest level of patient safety while promo ting the innovation and the Competitiveness of this sector.

Medical Devices - EU Regulatory Framework (Source: European Commission - DG Health and Consumers)

Revision of the Regulatory Framework for Medical Devices

On 26 September 2012, the European Commission ADOPTED A Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices whichwill, once ADOPTED by the European Parliament and by the Council, replace the three existing medical devices directives.
The EU regulatory framework actually Consists of Directive 93/42/EEC for Medical Devices (MDD), Directive 90/385/EEC for implantable medical devices and Directive 98/79/EC including AIMDs for IVDs.
All three directives are Planned to be revised and Replaced by a new EU regulatory framework for medical devices. Actually two proposals are available:
A) Proposal for a regulation of the European parliament and of the council on medical devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 . This proposal is about replacing the Directives 93/42/EEC and 90/385/EEC.
B) Proposal for a regulation of the European parliament and of the council on in vitro diagnostic medical devices . This proposal is about replacing Directive 98/79/EC

Please find the considerations for a new regulatory framework for medical devices in safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals

The links in this section are Directly related to the documents from the EU medical device regulatory framework

sideline displays
2005-04-04 22:03:48 by -

Not a lap band survivor here, but

It still has a lot of dangers and complications. Here's an online article (5 years old):
FDA panel refuses to endorse obesity 'Lap-Band'
The Lap-Band device
June 19, 2000
Web posted at: 8:45 PM EDT (0045 GMT)
WASHINGTON (CNN) -- A government advisory committee refused to give its seal of approval Monday to a weight-control device that's been used in Europe for seven years - - but has run into medical difficulties during its U.S. trials.
By a 6-4 vote, the Food and Drug Administration advisory committee concluded there was insufficient data to determine whether the device, called Lap-Band, was safe and effective

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