IVDR Templates

This collection contains templates for building and maintaining IVDR technical documentation and quality records. It covers common workstreams such as device classification, intended purpose, performance evaluation, scientific validity, analytical and clinical performance, post-market performance follow-up, labelling, declarations, and post-market surveillance.

Select and scale the documents according to the IVD's class, device type, novelty, users, specimen, testing environment, and conformity-assessment route. Keep intended purpose, claims, Basic UDI-DI, classification, performance characteristics, acceptance criteria, and variants consistent throughout the file. Connect performance evidence to risk management and turn unresolved questions into planned PMPF and PMS activities with defined methods and timelines.

These editable examples are not a complete IVDR submission and do not replace the regulation, applicable common specifications, MDCG guidance, standards, or notified-body expectations. Remove example language, justify exclusions, and make every record describe your actual device and evidence. Requirements also evolve during the IVDR transition and EUDAMED rollout, so confirm current dates, national routes, and submission formats before relying on a template operationally.