EU AUS Med Dvc MRA but Mfr’s Be Careful

This Mutual Recognition Agreement on standards and conformity assessment between Australia and the European Community has been in effect since 1 Jan 1999.  But the list of Conformity Assessment Bodies (CAB) for the EU doesn’t cover every EU Medical Device Notified Body and not all are approved for all product types.

So beware if your company is planning to use this system to check the EU Notified Body you plan on using is on the Approved List and for your product types.  To access the current list click here.