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
- Publication on IVDs used in combination
- Targeted letter: Stratus CS STAT Analyser manufactured by Dade Behring. TestPak and DilPaks for Troponin I and D-Dimer - Update
(160Kb) - Targeted letter: Stratus CS STAT Analyser manufactured by Dade Behring. TestPak and DilPaks for Troponin I and D-Dimer (106Kb)
- Urine dipsticks top tips leaflet
- Top 10 tips on POCT
- Cholesterol testing
- Blood glucose meters
- Laboratory One Liners
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:
- Management and Use of IVD Point of Care Test Devices
- DB 2002(02) Management of In Vitro Diagnostic Medical Devices
- DB 2006(05) Managing Medical Devices
- Point of Care Testing (POCT) Top Ten Tips
- Regulatory publications
- MHRA safety warnings
- Targeted letter: Stratus CS STAT Analyser manufactured by Dade Behring. TestPak and DilPaks for Troponin I and D-Dimer - Update (160Kb)
- Targeted letter: Stratus CS STAT Analyser manufactured by Dade Behring. TestPak and DilPaks for Troponin I and D-Dimer (106Kb)
- MDA/2006/070 LifeScan OneTouch® Ultra®, Lifescan InDuo® and Lifescan Pocketscan® blood glucose meters
- MDA/2006/035 - FreeStyle™, FreeStyle Mini™ and MediSense Optium Xceed™ blood glucose meters manufactured by Abbott Diabetes Care
- MDA/2005/051 All biochemical test kits for the identification of Neisseria gonorrhoeae (N. gonorrhoeae)
- MDA/2005/036 Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay
- MDA/2005/033 Medisense Optium Xceed, Therasense FreeStyle Mini and Therasense FreeStyle blood glucose meters
- MDA/2005/012 Hema Technologies Bilirubin Stat and Bilirubin Plus analysers
- MDA/2005/011 Oxoid cefpodoxime combination antibiotic susceptibility discs
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:
- Background note on the IVD Medical Device Directive
- Bulletin 12 - Sale and Supply of In Vitro Diagnostic Medical Devices (IVDs) (122Kb)
- Guidance - In House IVDs
- Guidance note 18 for registration of Persons Responsible for Placing In Vitro Diagnostic Medical Devices on the Market (226Kb)
- Guidance note 19 on In Vitro Diagnostic Medical Devices Directive 98/79/EC (320Kb)
Other useful sites
- European Commission's medical devices homepage (external link)
- European Commission MEDDEVs guidelines on medical devices (external link)
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 3080 7309
Khalid Razak khalid.razak@mhra.gsi.gov.uk
Tel: 020 3080 7200
Mojisola Ajeneye mojisola.ajeneye@mhra.gsi.gov.uk
Tel: 020 3080 7271
Bina Mackenzie bina.mackenzie@mhra.gsi.gov.uk
Tel: 020 3080 7229
For regulatory advice on IVDs, please contact us on telephone number 020 3080 7318
