The main points from this module are as follows:
An active implantable medical device (AIMD) is any active medical device that is meant to be completely or partially incorporated in the human body for therapeutic or diagnostic objectives, and which is meant to reside in that position internally.
The Active Implantable Medical Devices Directive is also denoted with an alphanumeric code i.e. 90/385/EEC. The directives apply only to active implantable devices. AIMDD will be replaced by EU MDR; the enforcement of EU MDR is delayed because of COVID-19.
In-Vitro Diagnostic are medical devices and accessories utilized to carry out tests on samples, for instance urine, blood, tissue, taken out as sample from the human body to aid the recognition of infection, analyze a medical condition, avoid disease or examine drug therapies.
The In-Vitro Diagnostic Directive (IVDD) is referred to as 98/79/EC. It was introduced in the late 1998, and its compliance became mandatory on December 7, 2003.
Medical Devices Directive (MDD) is also referred as 93/42/EEC of the European Union (EU). It furnishes the fundamental requirements for manufacturers and importers for the CE marking. It will also be replaced by EU MDR.
Due to COVID-19, EU MDR was supposed to be enforced on 25 May 2020. Its enforcement is extended for an year to May 2021.
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