• Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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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    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...
  • Regulatory NewsRegulatory News

    Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins

    The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union , setting in motion the timeline for implementation of the new regulations to commence on 25 May. Gert Bos, executive director at Qserve Group and a RAPS board member, explained to attendees of the MedCon conference in Cincinnati on Thursday some of the difficulties that industries will face over the ...
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    RAPS Increases Investment in Europe

    • 20 April 2017
    RAPS is stepping up its presence in Europe and expanding its European team in response to growing membership demand from those involved with the regulation of healthcare and related products. In the last 12 months, RAPS, the largest global organization for regulatory professionals in the healthcare, medical device, biologic and pharmaceutical sectors, has seen its European member base grow by approximately 19% to more than 1,500 members across 29 countries. R...
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    UPDATE: RAPS Seeks Authors for EU Fundamentals Book Deadline Extended

    • 30 March 2017
    The eighth edition of Fundamentals of EU Regulatory Affairs will be published in December 2017. RAPS currently is seeking authors for chapters, which will be due no later than 1 August 2017. If you would like to contribute to this book, please review the list of currently available chapters below and send your CV and your preferred chapter(s) to Pam Jones, senior editor, at pjones@raps.org or submit a volunteer application online. Emails or applications must be...
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    RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable

    No healthcare product, no matter how innovative or essential, will make it to patients without regulatory approval. Every regulatory professional knows this. But there is another critically important factor involved in getting treatments to patients that you may not know as much about—a concept known as market access. The elements of market access include reimbursement and the evidence necessary to secure it from payers, pricing and coverage policy. These areas ...
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    New RAPS Netherlands Chapter Announced

    A group of regulatory professionals in the Netherlands has formed a new official RAPS chapter there. The RAPS Netherlands Chapter is the newest in RAPS’ global chapter network and the second in Europe along with the RAPS Switzerland Chapter. The deal became official after representatives signed an agreement with RAPS leaders at 2014 RAPS: The Regulatory Convergence in Austin, TX, in October. RAPS now has 18 chapters in six countries, as well as affiliated networking groups...