COVID-19 Archives - Page 2 of 2 - Hygiene UK

Covid: UK hits 85m jab milestone amid discount push for young

Posted on 9 August 2021

Young people will be offered discounted takeaways and car travel to get their Covid jabs in a bid to boost vaccine uptake, the government has said. Food delivery and ride-hailing firms including Uber, Bolt and Deliveroo will offer incentives to people to get vaccinated. More than 68% of 18 to 29-year-olds in England have had […]

Covid vaccine set to be offered to 16 and 17-year-olds

Posted on 4 August 2021

UK experts are set to recommend all 16 and 17-year-olds should be offered a Covid vaccine, the BBC has been told. The Joint Committee on Vaccination and Immunisation stopped short of making the move last month, saying it was still assessing the benefits and risks. About 1.4 million teenagers will be included in the new […]

ACON’s Flowflex test receives CE mark for self-testing

Posted on 18 May 2021

ACON, one of the professional in-vitro diagnostic products manufacturers, has announced that its Flowflex SARS-CoV-2 Antigen Rapid Test has been CE marked for self-testing throughout the European Union. The CE certificate is issued by TUV SUD (CE0123) and validated from 14th May 2021 until 26th May 2024. SARS-CoV-2 Antigen tests play a critical role in the fight […]

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— Jackson Handling

Hygiene UK is great business providing essential supplies to essential services.

— Hope City Foundation

Huge range of products at great prices. At a time of desperate need many were taking advantage of people, but not Hygiene UK. They have helped us and have been nothing but perfect. If you’re looking for masks, gloves, aprons, etc please give the team at Hygiene UK a call!

— Global Office Supplies

Pleasure to deal with, great communication and overall service levels. Highly recommended.

— Seldram Supplies

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What is an IVD medical device?

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.

What does in vitro diagnostic use mean?

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.

What is In Vitro Diagnostic Regulation (IVDR)?

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.

When was the IVDR Implemented?

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.

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