Europe is experiencing a major overhaul, as the new European Union (EU) Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) revoke existing directives on medical devices. Regulatory changes are an effective step towards enabling the Intelligent Industry, learn more about Capgemini’s framework for a successful transition to MDR taking a structured approach, and with each of the key considerations in detail.
Successful regulation compliance is a pre-requisites for medical devices launch in the market. Medical devices require explicit adherence to specific content and format requirements as every regulatory agency has unique requirements, and these complex requirements often change. The new European Union Medical Device Regulation (EU-MDR) and In-Vitro Diagnostic Regulations (IVDR) revokes existing directives on medical devices. To keep up with rapid modernization in technology and medical sciences, the European Commission has introduced urgent reforms for better consistency, traceability, transparency in regulatory processes, and monitoring of post-market performance.
With fast-approaching deadlines, it is imperative for medical device manufacturers to adopt a strategic approach to sail through this journey smoothly. Updated regulation requirements need thorough review, planning, and time for remediation. It is advisable for organizations to take a structured approach, proper planning, and management, trainings, allocate enough skilled resources and budget, and use of process automation.
Read our point of view to understand the impact the EU MDR will have on the industry and how manufacturers should judiciously address and mitigate risk.