Guidelines

A mixture of finalised and draft guidelines are published by MCDC. We will update this link when the final guidelines are published. We provide a link for your convenience. (Please report any dead links)

• DRAFT Guidance Document – Medical Devices Regulatory System V1:19/01/2005

• Designation Of Conformity Assessment Body (CAB)

• Common Submission Dossier Template (CSDT) of IVD

• Medical Device Product Grouping (as a single unit, a family, an IVD test kit, a system or a set)

• Essential Principles of Safety and Performance for IVD [in vitro diagnostic]

• Conformity Assessment for IVD Medical Devices

• Common Submission Dossier Template (CSDT) of IVD Medical Device

• IVD Medical Device Classification System