[Blog] Medical Devices and In-vitro Devices: The journey to MDR and IVDR implementation
Since the European medical device regulation is experiencing a major overhaul medical device manufacturers have to adjust their strategic approach to go through this change smoothly. The EU regulators take this action an effective step towards enabling the Digitalization of the Industry.
Successful regulation compliance is a pre-requisites for medical devices to launch on the market. Medical devices require full adherence to specific content and format requirements as every regulatory agency has unique requirements. The new European Union Medical Device Regulation (EU-MDR) and In-Vitro Diagnostic Regulations (IVDR) replace fully the existing directives on medical devices. To keep up with rapid modernization in technology and medical sciences, the European Commission has introduced urgent changes for better traceability, transparency in the Track and Trace processes, and monitoring of post-market performance.
Updated regulation requirements need thorough review, planning, and time for remediation. It is advisable for companies in the industry to take a quick and structured approach, proper planning, and management, training, allocate enough skilled resources and budget, for use of process automation.