Three new MEDDEV documents have been released. The documents are a fantastic resource for medical device manufacturers placing product on the market or carrying out other related activities in the European Union. The documents are as follows:...
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The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be potentially implemented in the European Union (EU) during 2015/2016. These requirements echo changes made to the Therapeutic Goods (Medical Device) Regulations 2002 as amended which are specific to IVDs....
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At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force (GHTF)) a number of progressions were made. The Forum includes international medical device regulators from Australia, Brazil, Canada, Europe, Japan and the USA and has an aim to strategically accelerate international medical device regulatory convergence. It is hoped that this will provide medical device manufacturers with a more efficient path to certification worldwide. As indicated above, the Forum has fundamentally similar objectives to the......
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Recently the EU has come under heavy scrutiny for failing to produce adequate premarket clinical evidence that demonstrates efficacy and safety of innovative, higher – risk medical devices. Medtech experts from around Europe have collaborated to produce a report in which they argue that it is time to introduce randomised clinical trials (RCTs) in the EU for high risk medical devices (these are defined as innovative Class III medical devices and innovative implantable medical devices).The authors also propose centralising the evaluation process of these products....
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The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into force during 2012. The proposed regulation sets out conditions under which instructions for use in paper format may be replaced by electronic versions with respect to medical devices that are intended for exclusive use by professionals users and for which use by other persons is not reasonably foreseen. While acknowledging the benefits of e-labelling, the commission states that the possibility of providing instructions......
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