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Dekra : MHRA appoints to certify medical devices in UK - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.
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Revolutionizing ED Treatment: Eroxon Gel Hits Shelves - 0 views

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    The UK based Pharma giant Futura Medical Plc's lead product, Eroxon, a topical Stim-gel is now available on NHS prescription in England and Wales for the treatment of Erectile Dysfunction (ED). The Muti-Drug Resistant (MDR) approved alternative to PDE5i, Eroxon is available as an over-the counter off shelf at retailers like Boots and Superdrug; and is available on NHS prescription in England and Wales as a CE-marked medical device. Erectile dysfunction (ED), also known as impotence, is the inability to get and maintain an erection, typically concerning men over the age of 40 due to both, psychological and physical causes such as anxiety, depression, diabetes, and obesity. According to UK Conformity Assessed (UKCA), the approval of the medication is based on evidence from 2 Phase three clinical studies, which showed that 60 per cent of patients taking Eroxon achieved Minimal Clinically Important Differences (MCID) at 12 weeks.
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