• August Break Over, ENVI Returns to Consider Overhaul of EU Device, IVD Regulatory Frameworks

    • 10 September 2013
    European legislators are preparing to once again take up proposed changes to the way the EU regulates medical devices and in vitro diagnostics, they revealed in a 10 September 2013 announcement. Background Earlier in 2013, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) released draft reports calling for the establishment of more rigorous safeguard on medical devices and in vitro diagnostics after a series of notable regulato...
  • EU Parliament Prepares to Discuss Reauthorization of Two Regulatory-Focused Programs

    Members of the EU Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) have been on hiatus for much of the summer, tabling legislative plans on a wide array of regulatory topics including medical device legislation and transparency measures. But with their recess set to soon end, the committee has released a draft agenda of an upcoming meeting detailing new policies on two topics of regulatory interest: Clinical trials and product innovation. ...
  • European Parliament Committee Says Changes to Proposed Device Legislation Needed

    • 31 July 2013
    A new opinion report just published by the European Parliament's Committee on the Internal Market and Consumer Protection on the Committee on the Environment, Public Health and Food Safety's (ENVI) medical device and IVD proposals calls for changes to be made, citing the proposals' potential to be overly restrictive to the "free movement of products." Background In April 2013, ENVI made an unprecedented proposal to require many medical devices to undergo a premarket aut...
  • Draft IVD Proposal Would Strengthen Clinical Testing Requirements

    A new draft legislative report issued by a member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), Peter Liese, would make significant changes to the manner in which in vitro diagnostic products are regulated in the EU. The proposal follows a landmark proposal issued on 15 April 2013 by another ENVI member, Dagmar Roth-Behrendt, which called for medical devices marketed in the EU to be subject to a premarket assessment syst...
  • In Unprecedented Shift, EU Parliament Proposes Premarket Authorization for Medical Devices

    • 15 April 2013
    A key member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) today issued a draft report that calls for the establishment of a regulatory system that would see medical devices regulated more similarly to their pharmaceutical counterparts. Background Medical devices are less stringently regulated in the EU than in other regions, including the US. Instead of requiring a pre-market approval system for high-risk medical device...
  • Amended EU Clinical Trials Proposal Calls for Full Publication of Clinical Trials Data

    A newly-amended draft report published by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) seeks to advance a proposal that would overhaul the EU's clinical trials regulatory framework by repealing Directive 2001/20/EC and replacing it with a new regulation.  [ Editor's note: a previous version said it would be replaced with a new Directive. It is instead being replaced with a new regulation. ] The 55-page draft include...
  • Committee Calls for Improved Pharmacovigilance, New Labeling Requirements in Europe

    The European Parliament's Environment, Public Health and Food Safety Committee (ENVI) is calling for new methods to monitor, label and withdraw dangerous medicines on an EU-wide basis. Under new ENVI-backed legislation, any pharmaceutical product subject to a safety alert in one EU member state would trigger an automatic safety evaluation on an EU-wide level. "The new proposal would introduce an emergency procedure to be triggered automatically if, for example, a Member...