• Regulatory NewsRegulatory News

    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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    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse be...
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    EC Adds Six New Products to Borderline and Classification Manual

    The European Commission (EC) added six new medical and nonmedical products to its manual on borderline and classification cases based on the regulatory framework for medical devices.   EC’s manual is intended to serve as a tool to help manufacturers achieve time and cost savings by providing regularly updated clarifications. These policy updates clarify whether a product would be considered a medical device consistent with the European Medical Device Vigilance System (...
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    EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns

    The road to the new European medical device and in vitro diagnostic regulations (MDR/IVDR) has raised many concerns, but a European Commissioner recently attempted to ease some of these concerns during a plenary session of the European Parliament.   “Many of you said that I am optimistic and calm,” EU Commissioner for Internal Market, Industry, Entrepreneurship and small and medium-sized enterprises (SMEs) Elżbieta Bieńkowska said to a crowd of EU political group...
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    EU Releases Working Plan to Implement MDR/IVDR

    The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR). The EC’s working plan describes the legal basis, the expected adoption timelines and the current status of 12 implementing acts under MDR/IVDR and 12 other actions or initiatives. The only implementing act in the roadmap that has been completed so far involves the defined scope of notified body (NB) de...
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    New Law to Boost EU-level Cooperation on Health Tech Assessments

    In a boost for health technology assessments (HTA), the European Parliament recently adopted a new law that allows for greater cooperation among EU member states.   The law on HTAs specifically seeks to minimize duplicate assessments on new medicines and medical devices with the goal of removing unnecessary barriers to patient access and reducing administrative burden on industry. Following its 3 October adoption , the law was well-received by MedTech Europe as ...
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    EMA Sartan Investigation Flags Aurobindo Pharma, Raises Zhejiang Huahai Oversight

    The European Medicines Agency (EMA) announced Monday low levels of a probable human carcinogen have been detected in a third sartan made the second India-based company—Aurobindo Pharma—to have been linked to the international valsartan scandal.   The notice follows on the heels of the EMA’s decision to extend its review to include medicines containing an additional four sartans, with the one impacted by the suspension of Aurobindo Pharma’s European certificate of s...
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    Perspective: Regulatory Bill Could be Dangerous for FDA, Public Health

    A bill making its way through Congress could end up having "potentially disastrous consequences" for the US Food and Drug Administration (FDA) and public health, professors from the Program on Regulation, Therapeutics, and Law at Harvard Medical School and the Georgia State University College of Law, wrote in the New England Journal of Medicine this week. The bill, known as the Regulatory Accountability Act , has been promoted as a way to decrease burdensome regul...
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    Major Deregulation? FDA Withdraws Several Rules and Regulations Related to Medical Products

    Almost a year ago, President Donald Trump told pharmaceutical executives that his administration would cut 75% to 80% of FDA regulations, "at a level no one has ever seen before." Since those comments last January , the US Food and Drug Administration (FDA) has withdrawn the most rulemakings of any Department of Health and Human Services (HHS) agency, though only a handful are related to medical products (the others are tobacco related) and it's unclear how the wi...
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    First Implementing Act Under EU MDR, IVDR Open for Consultation

    The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday. Implementing acts allow the commission to tease out the intricacies of the legislation and this first one is related to the Notified Body product codes for medical devices and IVDs. The codes, included in the implementing regulation's annexes, are used to categorize the fields of expertise of the NBs ...
  • RAPS' LatestRAPS' Latest

    RAPS' New European Council Set to Shape and Support the Regulatory Profession

    • 19 October 2017
    RAPS is stepping up its presence in Europe and supporting its European expansion with the launch of its first ever RAPS European Council (REC). Following the announcement that RAPS plans to invest more than 2 million euro over the next three years to implement its growth plan in Europe, the new European Council will support RAPS’ growing member base and volunteer network across Europe with the information and education they need not only to ensure compliance with...
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    New E&Y MedTech Report Highlights Growth, Regulatory Questions

    Ernst & Young on Monday released a new report on how the global medical technology (medtech) industry grew by 5% in 2016, with US and EU medtech companies seeing net income increase 17%, though several regulatory and legislative question marks are on the horizon. In addition to the improvements seen in income and revenue growth in 2016 when compared to 2015, the report also shows that overall, US and European medtech financing increased 101% in 2016, to $43.9 billi...