editedbook
Publication: IIP Proceedings Year: 2022, Month: November Page No: 78-82, ISSN/ISBN: 978-93-95632-92-8, DOI/Link: https://rsquarel.org/assets/docupload/rsl2023B139BF27C86DEC3.pdf
OVERVIEW OF MEDICAL DEVICE REGULATION
Area/Stream: Medical Sciences, Authors: Dr. P. Charulata Sree Keywords: Medical devices, Regulatory affairs, Medical device regulation, Custom made devices. Book Name /series: Futuristic Trends in Medical Sciences, Volume 2, Book 21, Part 1, Chapter 8Publication: IIP Proceedings Year: 2022, Month: November Page No: 78-82, ISSN/ISBN: 978-93-95632-92-8, DOI/Link: https://rsquarel.org/assets/docupload/rsl2023B139BF27C86DEC3.pdf
Abstract:
Medical devices are designed and manufactured for overall healthcare, not concentrating specifically on nutritional or medical requirements. Government and Authorized Entities supervise the introduction and maintenance of the device. A new regulatory framework, MDR (EU) 2017/745 Medical Devices Regulation was officially published on May 5, 2017 and implemented on May 26, 2017. It is executed using a conformity assessment depending on risk based classification of the device. The regulation has introduced a UDI system (Unique Device Implementation) to support device traceability with the help of a numeric code or an alphanumeric code. Custom made devices (CMD) in a dental setting have to undergo certain legislative requirements in EU and UK to get their regulatory approval.
Cite this: Dr. P. Charulata Sree,"OVERVIEW OF MEDICAL DEVICE REGULATION", Futuristic Trends in Medical Sciences, Volume 2, Book 21, Part 1, Chapter 8, November, 2022, 78-82, 978-93-95632-92-8, https://rsquarel.org/assets/docupload/rsl2023B139BF27C86DEC3.pdf
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