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 hip, knee and shoulder joint implants have two years from July 1, 2012, to apply for their products to be transitioned from Class IIb to Class III devices in Australia, according to the Therapeutic Goods Administration (TGA). The agency issued the reclassification regulation last month, promising to follow up with details for industry on how to meet the Class III requirements. International Medical Device Regulatory Monitor