The final texts of the Medical Device Regulation/In Vitro Diagnostic Regulation, which will replace the current Medical Device Directive (93/42/EEC), Active Implantable Medical Device Directive (90/385/EEC), and In Vitro Diagnostic Directive (98/79/EEC) is now published.
These long awaited texts brings with it more scrutiny of technical documentation; the requirement for re-classification of more than 75% of IVDs; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices throughout the supply chain.
This will put a heavy burden upon medical device manufacturers with the requirement for more and higher documentation level having an impact on costs and not least time-to-market.
On this seminar we would like to take you through the new requirements and show you what these actually mean. In other words we would like to be your preferred partner in preparing for your readiness for the new MDR/IVDR so you can start acting within your organization.