Historically, the Australian TGA and EU notified bodies have performed conformity assessments of manufacturers technical documentation against each other’s regulatory requirements under the Mutual Recognition Agreement (MRA).
However, the MRA was updated on 1 January 2013 to exclude a number of device categories, including Active Implantable Medical Devices (AIMDs) and Class III devices, implantable intra-ocular lenses and intra-ocular visco-elastic fluids, and barrier devices indicated for contraception or the prevention of sexually transmitted disease. Other exclusions include some specific combination products with medicines or biologicals. The Amending Act also details a redefinition of “manufacturing”, and an extension to scope to include lower risk classes of radioactive medical devices. For more information on the changes implemented in the Amending Agreement, see our eNews update.
Both the TGA and EU remain in discussion during this confidence building stage, to ensure that the conformity assessment bodies engaging in reviews are capable and competent.
How does this affect my certificate?
Certificates issued by a European notified body under the MRA before 1st January, 2013, will remain valid until the date of expiry, or January 2018, whichever is earlier.