Medical Devices IVD

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THE IN-VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE (IVD) 98/79/EC

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

Competent Authority. The UK Government has appointed the Medicines and Healthcare products Regulatory Agency (MHRA) 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 ISO 13485:2012. This is an interpretation of the widely used ISO9001standard revised to suit the particular requirements for Medical Devices.

Essential Requirements. The IVD lays down the Essential Requirements for In-Vitro Diagnostic 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 screening may also be subject to a greater degree of vigilance.  A Quality Management System to ISO 13485 is a requirement.
It is important to use the Harmonised Standards to meet the Essential Requirements. Several standards are very specific and need to be complied with.

 

Risk Management

Risk Management to EN ISO 14971:2012 is a requirement for all In-vitro diagnostic devices. For further details see Risk Management or contact Atlantic Bridge Ltd.

 

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.