TGA published guidance on clinical evaluation

Publication date: 2017-02-02

Based on MEDDEV 2.7.1 the TGA developed its own Guidance Document  "Clinical evidence guidelines" for submission in Australia. It includes on top of the requirements that are already known from the MEDDEV Guidance typical problems and expected contents of CERs.

Although not being intended for the European market it may include some ideas to improve the existing clinical evaluations.