News

Brace yourself: New UK medical device regulations set to sweep self-test kit ranges off the market!

Monday 24th July 2023
SELFCHECK

With new UK medical device regulations just around the corner, it is now more important than ever that multiple retailers consider the impact on self-testing kits, and take action to ensure continuity of supply. Until the UK left the EU following Brexit, the regulations applying to professional laboratory tests and self test kits, were the EU regulations, known as the In Vitro Diagnostic Directive 98/79 EC (IVDD). These EU regulations were updated in 2017, with a 5 year transition period, as reform was greatly needed to protect patient safety by improving the quality, safety and reliability of medical tests and to properly regulate new products. These new regulations are the EU Regulation for In Vitro Diagnostic Medical Devices 2017/746 (IVDR). The…

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Own-label opportunities for self-test kits

Thursday 1st June 2023
SELFCHECK

If you are considering launching your own brand of self-test kits in the UK, check here for further information on self-test own-label opportunities

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Position statement on self-test kits

Thursday 25th May 2023
SELFCHECK

With reference to the position statement published by the RCGP on non-symptomatic self-tests this week, our response can be found here

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New Pregnancy Test from SELFCHECK

Tuesday 21st March 2023
SELFCHECK

Clearblue and First Response are the market leaders, and household names when it comes to branded pregnancy tests in the UK, offering consumers reliable results, and a brand they can trust. Ultra-low cost pregnancy test alternatives are also available in discount stores and supermarkets. All the pregnancy tests meet the necessary regulatory requirements and are simple to use. So why has SELFCHECK decided to enter the pregnancy testing market with a mid-range priced product? SELFCHECK has been providing a wide range of health-screening blood and urine tests for over a decade, and are known for their exceptional customer service. The SELFCHECK range, including their new urine pregnancy test, is assembled at their laboratories based at the OpTIC Technology Centre in North Wales,…

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Hay fever or a cold? How can you tell?

Thursday 16th March 2023

Pollen is released from different plants at different times of the year. Knowing when your symptoms occur can help you identify the likely trigger. Hay fever is the most common seasonal sensitivity. Hay fever symptoms can be experienced all year and may be confused with a cold. They can also trigger more severe conditions such as asthma, cough, wheezing and shortness of breath. Other allergy symptoms may include; frequent bouts of sneezing runny, itchy or blocked nose watery, itchy red or sore eyes itchy sore throat and tongue headache and loss of concentration Pollen may be from trees, grasses and weeds with increase in symptoms coinciding with the flowering of these plants. Trees can cause symptoms during spring, grasses in the…

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Should your patient self-test?

Friday 18th November 2022
Dr John Rees

Although self-test kits can provide information about a patient's health, a test result by itself is not a diagnosis. Responsible self-test manufacturers should tell their customers that if they are concerned about their symptoms to speak with their doctor or pharmacist - and not buy a test kit. Medical tests are usually only requested by doctors after first taking into account their patient's symptoms and clinical history, rather than testing first, and then working out how this relates to symptoms. Doctors are rightly concerned that the wide-spread use of self-testing kits could increase the burden on already overstretched NHS services. Although currently, there is no evidence that this is happening. Similar concerns were expressed by doctors almost 50 years ago, when…

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Why self-test kit suppliers must provide access to professional customer support

Friday 23rd September 2022
Dr John Rees

In an ideal world, medical self-test kits would be provided to patients by their doctor or a pharmacist, who would also be in a position to provide advice about how to use the test and interpret the results. However, difficulties getting GP appointments, time constraints during consultations, the funding system for NHS diagnostics in primary care, and subsequent delayed referral for laboratory tests, means that this is unworkable. Current medical device regulations stipulate that manufacturers of self-test kits must perform user trials with laypersons to show that the majority of people can perform the test and interpret their results correctly. Nevertheless, it is inevitable that a small, but important, proportion of users will, despite their simplicity, misinterpret the instructions, or will…

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Tighter regulation for self-test kit distributors

Friday 5th August 2022
J R BIomedical Ltd

All self-test medical devices are strictly regulated in the UK, and EU. Following brexit, since January 2021, all tests sold in the UK have to be registered with MHRA. Further, new regulations will also come into force on the 1st July 2023 and are likely to mirror those of the In Vitro Diagnostic Regulations (IVDR) currently in force within the EU. Stricter legal requirements for distributors of self-test kits One of the key changes of the new IVDR is that for the first time, responsibilities will be imposed on the distributor, as well as the manufacturer. For instance, it will be mandatory for distributors to have credible evidence of full traceability of products, suitable storage facilities and compliance with the IVDR standards, such…

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Iron deficiency anaemia - do you know the symptoms?

Monday 1st November 2021
SELFCheck

Iron deficiency anaemia is a common, major, and global public health problem. Women of childbearing age and pregnant women are at particular risk. Common symptoms of iron deficiency can include headaches, tiredness, lack of energy, palpitations, and hair loss. Measurement of specific biomarkers in the blood, such as ferritin, are a simple and more reliable indicator of iron deficiency anaemia compared to a full blood count. Knowing that you have a low iron level can help you seek advice from your pharmacist and doctor to help you reduce the risks of long-term diseases associated with iron deficiency anaemia. The SELFCheck Iron Level Test is a quick, 10 minute, reliable immunodiagnostic test for the assessment of your ferritin level from a finger prick…

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Patients seek out self testing kits as blood tube shortage worsens

Monday 13th September 2021
SELFCheck

The COVID-19 pandemic has driven global shortages of blood test tubes which has already impacted the NHS and is likely to get worse before it gets better. Some doctors are facing difficult choices as to who to offer blood tests to and who will have to wait. According to the British Medical Journal, most of the blood tubes used by the NHS are manufactured by Becton Dickinson (BD) but supply chain issues for raw materials as well as an increased demand for blood tests are fuelling the problem. Whilst patients are being refused blood tests for common health conditions, companies who manufacture 'instant' self testing kits that are used at home, such as SELFCheck, are seeing a corresponding increase in demand. In…

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