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 Class IV devices that choose not to use a summary technical documentation-based license or amendment application must provide details on manufacturing and quality controls, a device-specific quality plan and process validation studies, according to a Health Canada final guidance. Applicants should also include a risk assessment and risk-reduction measures that satisfy the agency’s safety and efficacy requirements. International Medical Device Regulatory Monitor