Significant Change Within the Context on EU MDR

Summary

During the lifecycle of a device, changes are inevitable. These changes can occur for several reasons, some of which may be unexpected such as a sudden supply chain disruption, material shortage, etc. Significant change is cited twice in EU MDR 2017/745. The focus of this white paper is to delve into significant changes and what changes could jeopardize valid Directive 93/42/EEC (MDD) or 90/385/EEC (AIMDD) certs for legacy devices leading to the necessity of applying for a MDR cert prior to the end of the transition period as set by the European Union Law. This paper provides an overview summary of the recently updated guidance Medical Device Coordination Group (MDCG) document 2020-3 Rev 1 titled, Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.