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  • Regulatory NewsRegulatory News

    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...
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    BSI UK Becomes Second NB Designated Under IVDR

    The European Commission on Monday updated its NANDO database to include BSI Assurance UK Ltd as the second notified body (NB) designated under the In Vitro Diagnostic Regulation (IVDR). BSI said it is the first NB to achieve full scope designation, which covers all devices for IVDR. "This includes several new categories of devices with specific characteristics that were not covered by the In Vitro Diagnostics Directive [IVDD] such as cancer tests, genetic tests, physiol...
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    MDR/IVDR Guidance: MDCG Explains What’s Coming

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE). The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 202...
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    EC Unveils First Notified Body Designation Under IVDR

    The European Commission (EC) on Thursday revealed that Germany-based Dekra Certification GmbH is the first notified body (NB) to be designated under the EU’s In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022. The designation, which follows Dekra’s previous designation as the third NB under the Medical Devices Regulation (MDR) in August, comes as experts have warned that there may be a shortfall of IVDR-designated NBs . Similar concerns have been ...
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    TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

    The European Commission on Thursday announced that Germany’s TÜV Rheinland is the fifth notified body (NB) to be designated under the EU’s Medical Devices Regulation (MDR). A TÜV Rheinland spokesperson told Focus that beginning tomorrow, "we are accepting applications under MDR. We have also applied under IVDR [in vitro diagnostic regulation]. Our JAT [joint assessment team] audit under IVDR is scheduled to be during the first week of December and we expect to have ou...
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    EC Adds IMQ as Fourth Notified Body Designated Under MDR

    The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR). The announcement does not come as a surprise, as Italy’s Ministry of Health announced in late July that IMQ met the requirements of the regulation. The EC had also previously indicated in its rolling plan,  updated last Monday , that four NBs have been designated. The other three NBs to be de...
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    Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline

    European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues. According to the European Association for Medical Devices of Notified Bodies (Team-NB), 84% of notified bodies intend to submit their application in November, 8% intend to submit in December and 8% next year. More than half of the no...
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    EU Court of Justice Clarifies Product Liability for Notified Bodies

    The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives. But the court's decision was more about clarifying the role of notified bodies in a product liability case concerning faulty breast implants made by the now-defunct French manufacturer Poly Implant Prothese (PIP) and German notified body TÜV Rheinland than about deciding if the notified body was liable....
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    EMA Weighs New Guideline on Quality Requirements for Combination Products

    The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. EMA says the guideline will consider the data requirements with respect to quality aspects in relation to the safety and performance of the medical device, whether it is an integral component of the medicinal product or a stan...
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    MHRA Looks to Increase Medical Device Fees

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies. While the agency noted some concerns over the increased costs associated with the fees, it said that the "majority of respondents were content with the fee changes proposed." Last April, MHRA released its business plan for 2016-2017, warning of serious financial troubles for ...
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    European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (5 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Clarifies Stance on EC Certificates for Devices The Swiss Agency for Therapeutic Products (Swissmedic) has given medical device manufacturers affected by the fall in the number of notified bodies one year to restore the legal conformity of their products. Swissmedic’s approach to the situation follows the harmonized procedure adopted by the European Union. ...
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    What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains

    For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority. As the uptick in notified body closures increases, France’s National Agency for the Safety of Medicines and Health Products (ANSM) on Monday reiterated that medical devices may only receive marketing authorization with a valid certificate and under regular device surveillance by a notified bod...