Guidance for EU MDR – Systems and Procedure Packs

A Medical device system and/or procedure pack is a combination of medical devices that are packaged and sold together as a single product, targeting a specific medical function or clinical need.

This document will help you understand whether your products falls under the definition of systems and procedure packs as per the 1993 Medical Device Directive (MDD) and the new 2017 Medical Device Regulation (MDR), how to classify your product and which actions to take to get on track for compliance with new MDR requirements.

Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.

Our consultants are available, should you need further assistance in completing the documentation.