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CE mark

This page shows the latest CE mark news and features for those working in and with pharma, biotech and healthcare.

Safety first: AI adoption in the healthcare sector

Safety first: AI adoption in the healthcare sector

Regulatory compliance. Certain software algorithms will be regulated as medical devices and thus subject to CE marking, either through self- certification or through notified bodies such as the MHRA. ... CE marking is a certification mark that indicates

Latest news

  • Prix Galien opens for entries with new award Prix Galien opens for entries with new award

    Products granted a CE mark within a five-year qualifying period are eligible for entry.

  • EMA starts firming up its stance on personalised medicines EMA starts firming up its stance on personalised medicines

    The new In Vitro Diagnostics Regulation “foresees cooperation”between the medicines regulator and its medical device counterparts “in the evaluation of new companion diagnostics to obtain the CE label”. ... diagnostic, and therefore it too will

  • Danish Medicines Agency urges caution on health app use Danish Medicines Agency urges caution on health app use

    To be classified as a medical device an app must be able to make a diagnosis or treat a patient, and also be CE marked, the Agency explained. ... If it makes sense to use an app in a specific situation, it is important that the doctor or patient makes

  • Sanofi to develop a mobile app for insulin patients Sanofi to develop a mobile app for insulin patients

    Voluntis focuses on ‘embedding connectivity in therapeutics and medical intelligence in software’and last year gained FDA clearance and the European CE mark for the new mobile app.

  • Surviving Brexit Surviving Brexit

    In the case of low-risk (class I devices) the manufacture may affix the CE mark following a self-certification procedure. ... Once a CE-mark is granted it allows the product to be sold freely throughout the EU.

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  • Changes to look out for in Medical Devices Regulations Changes to look out for in Medical Devices Regulations

    PIP. In 2000, it was discovered that Poly Implant Prothèse (PIP) had been using industrial-grade silicone instead of the medical-grade specified for the CE mark in the manufacture of ... The CE mark for PIP implants was consequently withdrawn, and

  • Deal Watch June 2016 Deal Watch June 2016

    In Europe Cerus expects to apply for a CE Mark for the Intercept RBC System in the second half of 2016.

  • Pharma deals during November 2012 Pharma deals during November 2012

    The V2 is one of 5 hypertension-treating devices with a CE mark and will compete with Medtronic's “ Symplicity” (acquired from Ardian for $800m) and Covidien's “ OneShot” (acquired from

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