A rapid test for the detection of human immunodeficiency virus (HIV) infection using one small drop of blood obtained through fingerstick collection.
“1 in 7 people are living with HIV and undiagnosed. Late diagnosis remains a key challenge: in 2016, 43% of diagnoses happened at a late stage of infection.” – Public Health England
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An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.
In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes, cassettes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.
The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.
The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the EU commission and are stipulated to complete some of the requirements to be met.
All the usual methods of communication can be used, phone, email, and the contact form on the website. Whichever method suits your needs best, check out the website footer for our contact information. Additionally if you need a face to face meeting we are more than happy to come visit.
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