Developing the state of the art section of the CER: challenges and pitfalls
There is no doubt that establishing state of the art is a challenge. It ranges from key information on the medical condition to a neutral, comprehensive analysis of treatment options, […]
Why is it important to establish state of the art during the clinical evaluation?
The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the […]
How has MEDDEV 2.7/1 rev 4 changed the requirements around State of the Art?
Prior to MEDDEV 2.7/1 rev 4, guidance referred to state of the art only vaguely. MEDDEV 2.7/1 rev 3 requested the discussion of clinical data “in comparison with” and “taking […]
