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News from the European Union
  1. Richard Price
  1. Correspondence to Richard Price, Policy and Advocacy, European Association of Hospital Pharmacy, 3 Rue Abbe Cuypers, Brussels 1040, Belgium; richard.price{at}

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May 2013

Draft ENVI report calls for central authorisation for high-risk medical devices

A draft report of the European Parliament's Health Committee (ENVI) has called for a centralised procedure for assessing and approving high-risk medical devices for the European market similar to that in existence for medicines approved by the European Medicines Agency (EMA).

Reviewing the European Commission's September 2012 proposals for improving medical device regulation, the lead rapporteur for the European Parliament, Dagmar Roth-Behrendt (Germany, Social Democrat) has accepted the case made by stakeholders such as the European Social Insurance Platform and others that the delegated ‘notified body’ system of approval, whereby national competent bodies may approve a device for use across Europe (the Conformité Européenne (CE) mark), was insufficient in respect of those devices presenting highest risk of harm to patients. Ms Roth-Behrendt is proposing a system similar to that in place in America, where the Food and Drug Administration (FDA) centrally authorise devices. The system proposed in the draft report proposes a new Committee of the EMA be constructed to oversee the approval process.

Ms Roth-Behrendt's amendments to create central authorisation for class III devices are likely to be opposed by federations representing the medical device industry and may lead to a lengthy period of debate and discussion with the European Commission and national governments about the final changes, with a subsequent risk that the subject file will not be concluded by the time of the next European Parliament elections in 2014.

The European Association of Hospital Pharmacists has lobbied Members of the European Parliament (MEPs) to amend the Commission's proposals on medical device regulation in order to ensure the following:

  • Coordination between vigilance reporting requirements for medical devices and medicines in order to encourage overall health professional familiarity with reporting processes and to reduce unnecessary confusion.

  • Careful construction and implementation of new tracking and unique identification systems for medical …

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  • Competing interests None.

  • Provenance and peer review Commissioned; internally peer reviewed.