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    EC Offers Two New Guidance Documents on MDR/IVDR

    The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR. Under Article 15 of MDR and IVDR, companies are required to have at least one employee responsible for regulatory compliance with a degree in law, medicine, pharmacy, engineering or another relevant scien...
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    May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

    While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge,” the European Commissioner for Health and Food Safety said Friday that the industry and government “are on course to meet it.” Vytenis Andriukaitis’s comments at a meeting of EU Ministers for Employment, Social Policy, Health and Consumer Affairs (EPSCO) in Luxemburg followed concerns raised this week by German and Irish delega...
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    EU Device Industry Groups Call to Accelerate MDR Implementation

    With the EU’s new medical device regulation (MDR) coming into effect in less than a year, seven EU-based medical device industry groups on Wednesday called to accelerate the implementation of the regulation “to avoid severe disruption of product supply to patients and hospitals.” While acknowledging a mechanism in MDR to allow for a grace period for certain devices that must meet the 26 May 2020 deadline, the groups explain why that mechanism has two fundamental weaknes...
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    MDR, IVDR and ‘Navigating the Grey’ Key Topics at RAPS Regulatory Conference Europe Opening

    The RAPS Regulatory Conference Europe 2019 kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. The EU’s transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was a key point of discussion as multiple panelists expressed concern about the ti...
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    Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

    Switzerland’s medical technology lobbying group issued recommendations to manufacturers Thursday to prepare for different possible regulatory scenarios because of uncertainty with the Institutional Agreement between the EU and Switzerland (InstA). Stalling the InstA “directly affects the medical technology sector,” said Swiss Medtech. The group noted challenges with not knowing whether support for the InstA will be voiced and whether Switzerland and the EU’s Mutual Reco...
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    European and UK Health Authority Officials, Industry Leaders, Notified Body Reps, Other Experts to Speak at RAPS’ Europe Conference

    RAPS released the updated agenda for its upcoming European conference in Brussels, 13–14 May. Among the speakers for the inaugural RAPS Regulatory Conference – Europe 2019 are representatives from the European authorities, notified bodies and trade representatives, all thought leaders and stakeholders with crucial responsibilities in the effective implementation and functioning of the changing European regulatory environment. “Europe’s regulatory environment for med...
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    EU Device Coordination Group Offers Eudamed Guidance

    The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed. The two-page document on the registration of data elements explains how the text of the Medical Device Regulation (MDR) presents an inconsistency with regard to what different articles wi...
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    COCIR Pushes to Harmonize Device Standards

    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued a position paper on Tuesday to facilitate the harmonization of medical device standards. COCIR’s position paper set forth six recommendations on harmonizing device standards, citing an array of existing challenges such as the assessment process and the fixed publication schedule. Harmonized standards need revision to reflect changes to and increased regul...
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    MedTech Europe Flags MDR/IVDR ‘Burning Points’

    Notified body (NB) availability and readiness for implementation of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) stand out among “burning points” in need of authorities’ attention, according to industry group MedTech Europe. The group’s director of regulations and industrial policy, Oliver Bisazza, explained how time is running out on MDR/IVDR implementation, and not just because of the 2020/2022 deadlines, but also due to lack of progress an...
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    EU MDR/IVDR Coordination Group Urges Exemption Clarification

    The European Commission (EC) issued a new document Friday in which the group established by the EU’s new medical device regulations argued that clarification of Article 54(2)b is “extremely urgent.” The Medical Devices Coordination Group (MDCG) evaluated the three criteria in Article 54(2) of the EU’s medical device regulation (MDR), which will exempt certain class III and class IIb devices from the requirement to involve expert panels in premarket clinical evaluation c...
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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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    TGA Proposes 5 Medical Device Classifications in Line With EU MDR

    In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).  The consultations consider the current classification requirements in Australia for five specific medical device types and either propose new classification rules to be incorporated into the existing Australian medical device regulations or classification changes. Propo...