All Risk articles
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JournalThe EU Medical Device Regulation: Balancing innovation with regulation
The EU Medical Device Regulation (EU MDR) 2017/745 was introduced in response to the need for tighter regulation of medical devices (MDs) in Europe. However, with the increased regulatory burden, there could be potentially hundreds of unanticipated ramifications, particularly for smaller manufacturers and start-ups. By increasing regulation so significantly in a relatively short time period, the very rules which are designed to protect patients may prevent them from accessing the treatment they need and stifle innovation, as start-ups inevitably struggle under the weight of new requirements. This article assesses the delicate balance between innovation and regulation and analyses the relationship between the two.
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JournalNavigating the MDR’s heightened surveillance and performance requirements
Substantial changes to post-market surveillance, post-market clinical follow-up and the new requirement to include a summary of safety and clinical performance, have all placed greater obligations on medical device manufacturers. The changes introduced by the Medical Device Regulation (MDR), have the overarching objective of improving patient safety and providing greater ...