Regulatory Focus™ > News Articles > In Unprecedented Shift, EU Parliament Proposes Premarket Authorization for Medical Devices

In Unprecedented Shift, EU Parliament Proposes Premarket Authorization for Medical Devices

Posted 15 April 2013 | By

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 devices, the EU has instead allowed devices to be marketed based on conformity to existing safety standards, which are overseen by notified bodies.

That system, however, has been under fire as of late. Thanks to several high-profile safety scandals-defective breast implants, faulty hip replacements and dangerous vaginal mesh implants among others-legislators had begun to study whether devices marketed in the EU were being adequately regulated, and if not, how to best do so.

That process has largely fallen to ENVI Rapporteur Dagmar Roth-Behrendt, an influential member of the European Parliament from Germany.

Her draft report, released on 15 April 2013, is sure to cause the EU medical device industry some significant concern.

New Opinions

The report, On the proposal for a regulation of the European Parliament and of the Council on medical devices, calls for the introduction of a new "marketing authorization procedure" that would for the first time see devices regulated in a similar manner to pharmaceuticals, which now require premarket approval prior to sale in a member state or the EU at large.

The report makes a huge number of recommendations. Among them:

  • The European Medicines Agency (EMA) will be charged with establishing a device review unit known as the Committee for the Authorisation of Medical Devices, a 35-member committee which will serve as a sort of CHMP for devices.
  • Opinions of the committee would be due within 210 days of initial receipt. Manufacturers may file an appeal with the agency within 15 days of receipt of a negative opinion. That request must be acted upon within 60 days.
  • A centralized marketing procedure would be created for implantable medical devices, innovative medical devices that utilize cell-based products, and combination products. A de-centralized marketing authorization procedure could be used for all other Class III-that is, high risk-medical devices.
  • The conformity assessment procedure would still be permitted for use by Class I, Class IIa and Class IIb medical devices.  Class II devices in particular should have an "appropriate level of involvement of a notified body." Class I devices are cleared under the "sole responsibility of the manufacturers" because of their low probability of risk.
  • Device products requiring safety trials would need to first obtain approval from an independent ethics committee before commencing.
  • Fees will be established on manufacturers to fund the work of notified bodies. These fees should be comparable across EU Member States
  • The creation of a "multidisciplinary advisory committee" of stakeholders that would be used to provide the European Commission and the Medical Device Coordination Group (MDCG)-a new advisory entity on medical technology, classification and regulation.
  • Devices would be unable to be reprocessed unless they are explicitly labeled as such. Devices labeled as single-use, "Should be real single-use and there should be only two possible situations for devices: single-use or reusable," the report explains. The default categorization is single use; manufacturers wishing for reusable labeling claims must provide scientific data to support this conclusion.
  • "Adequate levels of access for the public and healthcare professionals to those parts of Eudamed's electronic systems which provide key information on medical devices that may pose a risk to public health and safety is essential," the report states, indicating that any device registry would not be used only by regulators. That same Eudamed system would "serve as a tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several member states and … report serious adverse events."
  • The Eudamed system would also contain information regarding high-risk medical devices, including the national authority involved in a marketing authorization procedure and a summary of the device's safety and efficacy.
  • Notified bodies will be required to keep permanent "in house" staff trained in administrative, technical and scientific procedures, for which minimum requirements will be established. Other requirements include ones regarding independence, objectivity and impartiality of activities.
  • An electronic registration system will be set up to handle applications, including the name of the manufacturer, the name and risk class of the device, the procedure it must undergo, the country of application (if applicable), and associated reports and documents.

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