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Marketing Approval for Medical Devices in European Union


Affiliations
1 Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist – Kancheepuram, India
     

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The demand of medical devices has risen globally, especially in Europe. The devices regulated in Europe must ensure the safety and effectiveness of these products. There are various principles to approve the medical devices in the European market. The biggest companies are in Germany (27%), UK (11%), Italy, Switzerland, Spain and France (16%). The Europe has very good gobal impact in medical device marketing. The classification is based upon risk management, the medium and high risk requires the conformity assessment (CE marking) done by Notified bodies. There are four levels of classification of devices. Various EU directives that has impact on medical devices. International medical device regulatory forum (IMDRF), is followed by regulatory department of countries like Austrila, Brazil, Canada, China, EU, Japan, the United States, and WHO. The approved medical devices in European market must ensure the best protection of patient health. The development timelines for Noval drug and chemical entity take much longer time compared to medical devices. There are about 500,000 life supporting machines in which 20,000 are of generic group. Various rules on clinical evaluation and clinical investigation help in strengthening the regulatory system in Europe. To explore in marketing level premarket testing and postmarked vigilance is required.

Keywords

Medical Devices, CE Marking, Notified Bodies, European Market, IMDRF.
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  • Marketing Approval for Medical Devices in European Union

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Authors

D. Bhavyasri
Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist – Kancheepuram, India
K. Manikandan
Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist – Kancheepuram, India
R. Kamaraj
Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist – Kancheepuram, India

Abstract


The demand of medical devices has risen globally, especially in Europe. The devices regulated in Europe must ensure the safety and effectiveness of these products. There are various principles to approve the medical devices in the European market. The biggest companies are in Germany (27%), UK (11%), Italy, Switzerland, Spain and France (16%). The Europe has very good gobal impact in medical device marketing. The classification is based upon risk management, the medium and high risk requires the conformity assessment (CE marking) done by Notified bodies. There are four levels of classification of devices. Various EU directives that has impact on medical devices. International medical device regulatory forum (IMDRF), is followed by regulatory department of countries like Austrila, Brazil, Canada, China, EU, Japan, the United States, and WHO. The approved medical devices in European market must ensure the best protection of patient health. The development timelines for Noval drug and chemical entity take much longer time compared to medical devices. There are about 500,000 life supporting machines in which 20,000 are of generic group. Various rules on clinical evaluation and clinical investigation help in strengthening the regulatory system in Europe. To explore in marketing level premarket testing and postmarked vigilance is required.

Keywords


Medical Devices, CE Marking, Notified Bodies, European Market, IMDRF.

References