Marketing Approval for Medical Devices in European Union

• Published in: Research journal of pharmacy and technology 2019, Vol.12 (1), p.391-395
• Main Authors: Bhavyasri, D., Manikandan, K., Kamaraj, R.
• Format: Article
• Language: English
• Subjects: Classification; Councils; Manufacturers; Marketing; Medical device industry; Medical equipment; Medical technology; R&D; Regulation; Research & development
• ISSN: 0974-3618; 0974-360X; 0974-306X
• DOI: 10.5958/0974-360X.2019.00071.4

The medical device is administered in EEA- European Economic Area (EEA=EU+EFTA, totally 30 member states) by 3 New Approach Directives. i. 90/385 EEC, Active implantable medical devices. ii. 93/42 EEC, Medical devices. iii. 98/79 EC, IVD devices2, 3. Medical devices: "Any instrument, apparatus, appliance, software, material or other article, whether used solely or in combination, including the software intended by its maker to be used specifically for diagnostic and remedial purpose and required for its proper application, destined by the manufacturer to be used for human beings for purpose of * Diagnosis, prevention, monitoring, treatment or alleviation of disease, * Diagnosis, monitoring, treatment, alleviation of compensation for an injury or impairment, * Investigation, replacement or modification of the shape of a physiological process, * Control of conception5. The procedure for market authorization in medical devices, there are 3 levels of governmental involvement: * No attachment for (Class I devices), apart from notification to the national competent Authority. * Indirect attachment by supervision of the Notified Body that has direct participation (Class Is/Im, IIa/IIb, and III). * Direct, but partial, involvement of Competent Authority. [...]to determine the Declaration of Conformity (D°C) 11.