One project in particular that our team is currently working on is conducting a gap assessment of a client’s MDD Design Dossier against the new requirements of the EU MDR Medical Device regulation 2017/745.  The initial objective of the role was to evaluate product compliance to the General Safety and Performance Requirements (GSPR), Annex 1, Annex 2, and identify EU MDR “State of the Art” (SOTA) compliance gaps to harmonized standards to determine immediate mitigation needs.  The review scope included legacy product families which have been on the market under MDD CE certificate for > 20 years. 

With the new and modified MDR requirements, the legacy compliance MDD review identified significant gaps, requiring remediation of deliverables to support the EU MDR submission.  With our knowledge of the company products and processes, we have been retained to mitigate the gaps through collaboration with the client stakeholders as well as creation of the EU MDR submission for Notified Body review.