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Technical Documentation and Medical Device Regulation

December 5, 2018

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation. Technical documentation needs to be in compliance with the Medical Devices Directive (MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC (referred to as ‘MDD/AIMDD’ hereafter).

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Dasa

We are leaders in diagnostic medicine in Brazil, the largest company in the sector in Latin America and the 5th largest in the world. We work with clinical analysis, diagnostic imaging and molecular and genomic medicine, with a trajectory of more than 50 years. Each year, we carry out around 250 million tests - an expressive number, comparable to few in the health world.

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