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  • Regulatory NewsRegulatory News

    European Commission Issues Final Opinion on Metal-on-Metal Hip Implants

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) issued on 9 October 2014 its final opinion regarding the safety of Metal-on-Metal (MoM) joint replacements, and hip implants in particular. SCENIHR's report concludes th...
  • Regulatory NewsRegulatory News

    EU Scientists Clear Use of Dental Amalgam, but Call for Further Study

    One of the European Commission's (EC) top scientific bodies, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), is calling for public comment on a new report in which it largely downplays concerns about exposure to mercury in dental amalgam while saying that further study is needed. Background SCENIHR has long been interested in the issue of dental amalgam, a mercury-based filler that is used to treat dental problems like cavities and regu...
  • EU Launches Probe into Safety of Transvaginal Mesh

    The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a  scientific committee  which conducts risk assessments for EU officials-has announced it is launching an investigation into the safety of transvaginal mesh products used in urogynecologic surgery. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pel...
  • European Commission Report Calls for Restricted Use of Metal-on-Metal Hip Implants

    The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a scientific committee which conducts risk assessments for EU officials-has announced the publication of its initial draft assessment of the safety of metal-on-metal hip implants. Background Metal-on-metal hip implants have been plagued with controversy around the globe. The devices, which claimed to be similar enough to predicate devices made with non-metal parts, have...
  • EU Health Officials Say BPA in Devices May Adversely Affect Premature Infants, But Data Inconclusive

    • 30 January 2014
    • By
    The European Commission and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR), an influential committee whose role it is to investigate safety risks in health products, has announced that it has launched a public consultation into whether bisphenol A is safe for use in medical devices. Background Bisphenol A , more commonly known as BPA, is regularly used in the manufacture of plastics and epoxy resins. While it has been used in many consumer...
  • European Commission Committee Clears PIP Breast Implants of Major Health Concerns

    The European Commission has released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP), a French manufacturer whose products ignited a firestorm of controversy over the safety of medical devices in the EU after they were found to have been manufactured to deficient standards. Background The PIP scandal erupted in late 2011, when regulators determined that the company had bee...
  • EU’s Scientific Committees to Look at Synthetic Biology

    The European Commission's three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its implications for human and animal health and the environment, and the major gaps in knowledge necessary for performing a reliable risk assessment. Synthetic Biology is the term used to describe the creation of biological systems that do not exist in nature using engineeri...
  • EC Committees: Changes Coming to European Human Risk Assessment

    • 22 October 2012
    • By
    A new discussion paper generated by three of the EU's top scientific committee has called for a paradigm shift in the way regulators assess risks to human health from a hazard-driven process to one driven by exposure. The paper, Addressing the New Challenges for Risk Assessment , was issued by three of the European Commission's Scientific Committees: the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), the Scientific Committee on Consumer ...
  • EU Science Agency Calls for Experts, Information on Host of Medical Device Safety Issues

    The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published seven announcements calling for information and experts on a host of emerging and established regulatory issues related to several classes of medical devices. The 8 August announcements come in response to several requests that it update earlier scientific opinions or issue new ones where no earlier opinion exists. Nanomaterials and Metal-on-Metal Hip Imp...
  • EC: SCENIHR Issues Memorandum on Europe's Scientific Risk Assessment Process

    A memorandum issued by the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is intended to provide transparency to stakeholders on the Committee risk assessment process.  Risk assessments inevitably involve human scientific judgments and there are stressors to which humans may be exposed. The memorandum is intended to complement the draft SCENIHR report on the identification of emerging issues and the work of SCE...