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| CE Marking of In - Vitro Diagnostic Medical Devices |
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| CE Marking of In - Vitro Diagnostic Medical Devices |
BACKGROUND
The In-Vitro Diagnostic Medical Devices Directive 98/79/EC applies to devices and accessories used in diagnostics and includes the related software. The classification includes:
- Diagnostic and monitoring equipment for alleviation of disease
handicap or injury- Blood group reagents
- Blood disease test kits
- Self-test Kits (Including pregnancy)
- Diabetes Test Kits
- Instruments
The UK Regulations will be introduced Mid 2000. The transitional period extends until 27th October 2003 (to be confirmed), after which the products and their accessories must bear a legitimate CE mark.
Competent Authority
The UK Government has appointed the Medical Devices Agency as the UK Competent Authority to regulate their safety, See the Medical Devices Section for fuller details.Notified Bodies
Are certification organisations, which carry out conformity assessment procedures. Under the Directive, Notified Bodies are responsible for any required assessment of Quality Systems, product testing and examination of documentation. Notified bodies are normally restricted to assessing particular types of devices. The Notified Body may subcontract testing to laboratories, but must retain the overall responsibility. The Quality System specifically designed for these Devices is EN 46000 with the assistance of EN928. This is an interpretation of the widely used ISO9000 series to suit the particular requirements for Medical Devices.Essential Requirements
The Medical Devices Directive lays down the Essential Requirements for Medical Devices. The essence of these requirements is that the device should be safe and accurate when in use.Particular requirements apply to self-test kits and certain reagent kits. Those kits used for block creeening may also be subject to a greater degree of vigilance. A Quality Management System is a requirement.
Some European Norms have been issued to expand and explain the Essential Requirements for particular areas including labelling.
Process
The Process for assessment and details on the required quality systems to be followed, closely resembles that for Medical Devices. For fuller information see our page on Medical Devices.
Atlantic Bridge Limited,
Atlantic House, PO Box 4800, Earley, Reading, Berkshire, RG5 4GB, England. Email: info@atlanticbridge.co.uk
Telephone : +44 (0) 118.969.7047 Fax : +44 (0) 118.901.4411 Devizes Office
Telephone : +44 (0) 1380.848170 Fax : +44 (0) 1380.840152