• Regulatory NewsRegulatory News

    MDCG guidance aims to help manufacturers implement UDIs under MDR and IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a   question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).   The 14-page document covers 25 questions regarding UDI device identifiers (UDI-DI), UDI labeling, UDI rules for systems and procedures packs and configurable devices, a...
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    US, EU Look to Mutually Recognize GMP Inspections by January 2017

    The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP). Progress on mutually recognizing GMP inspection has been ongoing since June , particularly as the US Food and Drug Administration (FDA) has observed at least eight audits since 2014 and as six additional aud...
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    European Commission Pushes for Closer Convergence With US on Device Regulations

    As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations. The text of the proposal discusses some of the high-level themes of what both sides would to like find more common ground on, including the convergence of technical and clinical requirements applicable to devices; removing...
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    Plans for US Evaluation System for Medical Devices Take Root

    The US Food and Drug Administration (FDA) is going to make a big push over the next two years to use more real-world evidence to track the safety of medical devices. The plan, outlined in FDA’s Center for Devices and Radiological Health’s (CDRH) Strategic Priorities report for 2016-2017, will see the agency building a national medical device evaluation system as part of efforts to leverage real-world evidence to more quickly identify safety signals, particularly through ...