In vitro diagnostic medical devices: guidance on legislation
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Regulatory guidance for medical devices, Patient safety, and Medical devices regulation and safety
- 19 August 2013
Guidance explaining the main features of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
PDF, 100KB, 15 pages
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This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices and explains the main features of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
- the scope of the directive
- the assessment process
- in-house manufacture
For further information about the regulation of IVDs see:
Published: 19 August 2013