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This guide is intended only as a summary. You can find more information on the IVD Directive using these links.
- MHRA introduction to the IVD Directive
- British In Vitro Diagnostics Association (BIVDA)
What is the IVD Directive?
The In Vitro Diagnostic Medical Device Directive (98/79/EC) is the third in a series of European Directives on medical devices intended to provide regulations for the safe manufacture, supply and use of devices in Europe. Similar regulations have been in place in the USA by the FDA for many years.
- The IVD Directive has become UK law under the Consumer Protection Act (Medical Device Regulations 2002).
- All IVD products manufactured after 7th December 2003 intended to be sold (or given away) within the EU, must comply with the Directive and this is shown by the CE mark on the packaging.
What products does it cover?
‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state
- concerning a congenital abnormality
- to determine the safety and compatibility with potential recipients
- to monitor therapeutic measures.
Note that specimen receptacles are also considered to be in vitro diagnostic medical devices. Specimen receptacles are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Classification of IVD Products According to Risk
Within the classification there are 4 levels of risk requiring different actions on the part of the manufacturer to attain the CE mark.
- General (products not included in the below groupings)
- Products for self-testing
- Annex II, List A (blood groups, HIV (1 & 2), HTLV I and II, and Hepatitis B, C, & D)
- Annex II, List B (blood groups, chlamydia, rubella, cytomegalovirus, PSA, and toxoplasmosis)
What does it exclude?
Products that are exclusively used for research purposes are exempted from an evaluation to the IVD Directive, as no performance claims are stated. These products will be clearly marked with ‘Research Use Only’ on the labels.
Look for the CE Mark
The CE-marking logo is the visible evidence that a product fulfils the requirements of the applicable Directives and can be sold throughout the EU and to EFTA countries. The CE mark means that the device meets a defined set of minimum safety requirements listed in Annex I of the IVD Directive. It’s application to IVD products may be new, but you will already have seen this mark on other consumer products e.g. Toys. Where products are classified as higher risk, the CE mark shows the number of the notified body by the CE mark.
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