Meddev

The MEDDEV 2.7.1 is the most important technical guidance document for literature search under the MDR in the medical device regulatory industry. Since the MDCG documents do not currently offer any concrete guidance on [...]

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of medical devices in a "clinical evaluation"’. With the breast implant scandal in [...]