Technical Documentation Requirements for Medical Devices Approval in European Union and a Detailed Emphasis on Air-way Products

Shanmukhi  Kondrath; Ramaiah Maddi

doi:10.37022/jiaps.v6i3.244

Shanmukhi Kondrathi Department of Pharmaceutical Regulatory Affairs, Hindu College of Pharmacy, Amaravathi Road
Ramaiah Maddi Department of Pharmaceutical Regulatory Affairs, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, A.P., India

DOI https://doi.org/10.37022/jiaps.v6i3.244

Abstract

The technical documentation to be drawn up by the maker ought to be introduced in an unmistakable, coordinated, promptly accessible, and unambiguous way. It will remember for specific the components recorded as per Annex II of EU MDR 2017/745. The Air-Way is the way that air follows to get into and out of the lungs. There are a few kinds of Air-way devices are there on the lookout. New items will conceivably further develop patient prosperity altogether however will require sensible administrative control to boost the advantages. The orderly methodology is planned on a central theoretical level that underlies the substantial necessities that could be changed during the years to follow. The current article gives an itemized accentuation on Air-way items and their tech documentation necessities.

Keywords: Medical device, Technical documentation, Medical device Approval process, Air-way products

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