Digitalisation of Technical Documentation

The transition in the European Union (EU) regulatory landscape for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) to the Regulations ((EU) 2017/745 and (EU) 2017/746) brings with it a large step-up in the volume of documented evidence required to demonstrate the conformity of MDs and IVDs placed on the EU market. Manufacturers are faced with the continuous task of compiling and recompiling a very large and ever-shifting dataset into multiple fixed but overlapping reports for the purposes of audit by Notified Bodies and Competent Authorities. Likewise, Notified Bodies are tasked with reviewing these deliverables in many different formats from multiple manufacturers whilst keeping track of changes that may occur in the documentation during the course of the review.

To improve the efficiency of Technical Documentation management, MedTech Europe suggests exploring a transition to a harmonised model for the digitalisation of technical data. This would allow compiling on demand the deliverables required by a specific reviewer for a specific purpose. Such a harmonised approach can alleviate the practical and cost burdens of compliance on manufacturers and other stakeholders and improve the efficiency of data review processes.

Read our full position paper below.