Medical device regulation – an explainer

[UPDATE: The Independent adds some detail on the lack of data held the MHRA: “it did not have accurate data for the total number of implants inserted, making it impossible to calculate the true rupture rate.”]

Sarah Boseley provides some background to the PIP breast implants saga with a very informative piece on how implants and other medical devices are regulated.

The top angle is that these devices only require the same certification as toys, but there’s much more below that which is of particular use to anyone wanting to investigate medical devices or piggyback on the PIP story to look for similar problems. Continue reading