home.aspx
 
. https://pharmaceutical.report/Resources/Whitepapers/b94c01dc-a1cb-4b80-8a70-b8ca3717e347_White-Paper-Technical-Documentation-Web-v3.pdf
whitepaper
SHARESHARESHARE
TECHNICAL DOCUMENTATION AND MEDICAL DEVICE REGULATION
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). DOWNLOAD