In vitro diagnostic medical devices (IVDs)

This section includes background and publications about in vitro diagnositics (including testing kits).

What is an in vitro diagnostic medical device (IVD)?
Broadly, a device is an IVD when the manufacturer has intended its use for the in vitro diagnostic examination of specimens derived from the human body. IVDs can include:

  • blood glucose meters, home pregnancy tests, test kits used in hospital laboratories
  • reagents, calibrators and control materials, whether supplied alone or as part of a kit
  • analyser systems, analytical instruments, apparatus or equipment
  • Point of Care testing and self-testing devices
  • specimen receptacles (including blood collection tubes) specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro examination
  • accessories to IVD devices. These are 'intended specifically by the manufacturer to be used together with an IVD to enable that IVD to be used in accordance with its intended purpose'. A multi-well tile on which immunoassays are performed would therefore be an IVD accessory, while a volumetric flask would be general laboratory equipment


What's new in IVDs


Reporting adverse incidents
Home users/members of the public, clinical laboratory professionals, other IVD users and IVD manufacturers are encouraged to report incidents, which produce (or may potentially produce) unwanted effects involving patient, users or others. Unwanted effects involving patients may include misdiagnosis or inappropriate treatment.

You can report an adverse incident via this website:

Manufacturers should refer to The Vigilance System (817Kb) for guidance on their requirements to report adverse incidents. They should also consult the IVD Directive for fuller information.


Publications
The MHRA produces a number of publications for a wide range of audiences including device users and manufacturers. Below are some IVD specific publications:


Regulatory information
The MHRA has published several documents on the regulatory aspects of IVDs and the IVD Medical Device Directive. Below are links to some of these documents:


Other useful sites


Evaluations
The MHRA Device Evaluation Service published several pathology evaluation reports specific to IVDs. From 1 September 2005, the Centre for Evidence-based Purchasing (formerly the Device Evaluation Service) transferred from the MHRA to the NHS Purchasing and Supply Agency. The MHRA website will no longer publish new evaluation reports. To view new evaluation reports visit the Centre for Evidence-based Purchasing website at www.pasa.nhs.uk/cep.


Contacts
For further information on the investigation of adverse incidents involving IVDs (including test kits for virology, clinical chemistry, point of care tests, home tests, immunology, blood transfusion, haematology, coagulation, genetic tests and any other IVD) please contact any the following:

Stephen Lee stephen.lee@mhra.gsi.gov.uk
Tel: 020 7084 3309

Khalid Razak khalid.razak@mhra.gsi.gov.uk
Tel: 020 7084 3200

Mojisola Ajeneye mojisola.ajeneye@mhra.gsi.gov.uk
Tel: 020 7084 3271

Bina Mackenzie bina.mackenzie@mhra.gsi.gov.uk
Tel: 020 7084 3229

For regulatory advice on IVDs, please contact tel: 020 7084 3318


Page last modified: 03 March 2008