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    EU Committee Urges No-deal Brexit Transition Period for Medical Devices

    The European Commission (EC) should act in the “best interest of citizens” and establish a transition period to allow manufacturers to keep placing medical devices certified by a UK Notified Body (NB) on the EU market under a no-deal Brexit, trade association COCIR urged Wednesday in an open letter. The European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry—otherwise known as COCIR—expressed its concerns around the increasingly lik...
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    RAPS Launches Europe Conference as European Regulatory Environment for Medical Products Faces Sweeping Changes

    RAPS will hold its inaugural RAPS Regulatory Conference – Europe 2019 in Brussels, 13–14 May. It comes as the European regulatory environment for medicines, medical devices and in vitro diagnostics (IVDs) is undergoing major changes, and both regulators and the regulated companies making life-saving and life-sustaining medical products face myriad uncertainties. The EU’s new Medical Device Regulation (MDR) is set to take effect next year. A new In Vitro Diagnostic Re...
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    MHRA Sets No-Deal Brexit Process for Pharma Submissions

    Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU without reaching an agreement by the end of this month. The guidance, posted Monday, describes the steps applicants and sponsors need to follow for access to the new MHRA gateway for UK submissions from day one post-Brexit in a no-de...
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    EMA Closes London Office, Preps for New Time Zone

    After 24 years in London, the European Medicines Agency (EMA) on Friday has officially departed and is on its way to Amsterdam following a Brexit relocation vote in November 2017. EMA's permanent Amsterdam headquarters, a tailor-made building in the Zuidas business district, are planned for completion next November. On a temporary basis, the Dutch government has granted EMA the Spark building in the Sloterdijk area of Amsterdam until the permanent building is completed....
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    EU Regulatory Roundup: UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments   The United Kingdom has created a logistics hub and bought tickets from ferry operators to mitigate the risk that a no-deal Brexit will disrupt the supply of drugs and medical devices.   In the event of a no-deal Brexit, preferred shipping routes between Dover, Calais and other towns and ...
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    MHRA Spells Out Post-Brexit Regulation of Medical Devices Under No-deal Scenario

    With just about a month left until Brexit, the UK regulatory authority for medical products issued updated guidance on what the medical device industry needs to know about the future device regulation under the increasingly likely scenario of Britain leaving the EU without a deal on continuing resolutions. From requiring a new role as a UK Responsible Person and additional importing and distributing obligations to a slew of new registration and classification requiremen...
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    EMA Urges Sponsors to Prep for Spike in Brexit-related Submissions

    The European Medicines Agency (EMA) urged marketing authorization holders (MAHs) looking to make Brexit-related changes in March to do so “as early as possible during the month,” citing a 50% expected increase in the number of marketing authorization changes over the next three months. EMA’s notice—posted on Tuesday—calls on MAHs that intend to submit Brexit-related Type IA and Type IB variations next month to do so well before the 29 March deadline for Britain to leave...
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    Survey Highlights Looming Shortfall of IVDR-designated Notified Bodies

    Nearly half (46%) of surveyed notified bodies (NBs) recently indicated that they do not intend to apply for designation under the European in vitro diagnostic regulation (IVDR), adding fuel to the contentious issue over the anticipated lack of NB availability to support industry demand. Team-NB, the European association for medical devices of NBs, conducted the survey “following interest form the sector concerning the designation process in the framework of the IVDR r...
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    UK Looks to Ensure Pharma Submissions Can Continue Under No Deal Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to ensure that if the UK leaves the EU without a deal, pharmaceutical companies can continue to submit regulatory and notification information to the UK. “If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA,” the agency said. ...
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    EU Lists First Notified Body Under MDR

    BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR). The new NB designation—the first-of-its-kind to be listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) database—comes months before the timeline the Notified Bodies Operations Group had estimated in 2017 guidance for NB designation and notification. The scope of B...
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    Falsified Medicines Directive: MHRA Responds to Comments, Addresses Brexit Impact

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) last month responded to comments on its proposal to implement packaging safety features under the EU Falsified Medicines Directive (FMD) .   The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging of certain medicines, are detailed under Commission Delegated Regulation (EU) 2016/16...
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    MHRA Expands on ‘No-Deal’ Brexit Preparations for Drugs, Medical Devices

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on Thursday to propose and further clarify certain regulatory positions in case of a “no-deal” scenario as Brexit looms around the corner. The 14-page guidance document covers the current and possible future regulatory space for medicines and medical devices brought into the UK market, as well as clinical trials conducted in the UK. It was developed based on responses to MHRA’s Octob...