UK MHRA issues guidance on device eIFU, but doubt is cast on its value

The UK Medicines and Healthcare products Regulatory Agency has issued guidance on how medical devices manufacturers can provide an electronic format of their instructions for use (eIFU). However, the guidance has come…


The MHRA's new guidance on standalone software as medical device and DIA Euromeeting update

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…


EU 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…


EU Regulation on e-Labeling of Medical Devices expected to enter into force end this year

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 fragmented way….

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