EU Regulation on e-Labeling of Medical Devices expected to enter into force...
On 8 June the European Commission published a draft regulation on e-labeling as part of their WTO Technical Barriers Trade activities. Up to now, e-labelling was problematic and regulated in a...
View ArticleEU regulation of e-labelling of medical devices to apply as of 1 March 2013
On 23 September 2011 the draft of the e-labelling regulation that I wrote about earlier was discussed in the comitology committee for the Medical Devices Directive. I received the text of the amended...
View ArticleThe MHRA’s new guidance on standalone software as medical device and DIA...
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between...
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