Does anyone know if a comprehensive document exists anywhere that shows which Essential Requirement of the Medical Device Directive is covered by which Harmonised Standard?
I know that Europa has full list of standards that can be used to demonstrate compliance with the MDD, but the appear only in Standard Number order.

Thanks
James

I think if you dig deeper, you can get a list with their names. Each standard has an annex in the back that cross-references the clauses or subclauses with the essential requirements. However, the standards you use, depend on your product classification and type.

Hope this helps and good luck.

See ISO 16142:2006 Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

.....i am off to buy ISO 16142 and will also check out the sections at the back of the standards to see the link to ER's.

:thanks: