The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies. The final guidance, published July 6, discusses how notified bodies should assess lay user studies of self-test in vitro diagnostic (IVD) devices, labeling requirements and other information related to a device’s instructions for use (IFU). International Medical Device Regulatory Monitor