reprocessing

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Update on MDR/IVDR trilogue

The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December….

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White smoke: we have a general approach for the medical devices and IVDs regulations

Yes we can! We have a general approach for both the Medical Devices Regulation and for the IVD Regulation, agreed in the EPSCO Council last Friday. The press release also conveniently bundles…

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EP debate on devices revision – largely predictable, some surprise

Today was an interesting day for medical devices in Europe. We had the EU Parliament’s plenary debate on the medical devices and IVD regulation proposals, and the subsequent vote on the highly…

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ENVI vote results out: we have a draft legislative resolution

The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote…

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ENVI's 29 may debate on medical devices

The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very…

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Hold on to your seat: ENVI's Dagmar Roth-Behrendt report is here

Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary…

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Reprocessing of single use medical devices in the EU

On 28 April 2010 the European Commission published the SCENHIR’s opinion on reprocessing of medical devices, which was adopted by the SCENHIR on 15 April 2010. This opinion was commissioned pursuant to…

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