Critics of the EU MDR have long cautioned that certain new requirements, such as tightening up clinical evidence rules for high-risk products, could lead to some manufacturers leaving the European market altogether due to the costs of running clinical trials.
Medical devices made for use in children or to treat orphan conditions are “particularly vulnerable” to market withdrawals and action must be taken to mitigate such risks, according to researchers.
If no measures are taken, this could result in patient harm where no other devices are available for a certain condition, as is the case for a type of device...
