This post originally appeared on our sister blog, InsideMedicalDevices.  

As announced in our previous post, the rapporteur (i.e., the leader of the parliamentary process) for the new Regulation on medical devices, Mrs. Dagmar ROTH-BEHRENDT, has proposed the introduction of a pharma-like pre-marketing authorization regime for high risk medical devices in the EU.

In her recent report submitted to the ENVI Committee of the European Parliament (the parliamentary committee in charge of environmental and public health issues), Mrs. Dagmar ROTH-BEHRENDT criticizes the conformity assessment procedure involving notified bodies for high risk devices and proposes the creation of two types of marketing authorization procedures for those devices.  The authorization process would either be centralized (i.e., at EU level) for innovative devices, or decentralized (i.e., at national level) for other devices.  However, manufacturers required to use the decentralized procedure would have the possibility to apply for the centralized procedure.

A Committee for the Authorization of Medical Devices would be created within the European Medicines Agency (EMA) to operate the centralized procedure.  For the decentralized procedure, the mutual recognition principle would apply.  The mutual recognition principle is a principle whereby devices authorized in one Member State cannot be banned from sale on the territory of another Member State.  A newly created expert committee composed of Member State officials and chaired by the European Commission, the Medical Devices Coordination Group (MDCG), would act as a facilitator where disagreements arise over marketing authorizations between Member States. Where disagreements would persist, the Committee for the Authorization of Medical Devices would be requested to provide an opinion, the final decision being taken by the Commission.

Moreover, Mrs. Dagmar ROTH-BEHRENDT proposes the establishment of a publicly accessible electronic system for the registration of applications, the granting, the suspension and the revocation of marketing authorizations. The EMA and the Member States, as relevant, would be responsible for entering the information into the system.

There is no consensus among Members of the European Parliament to support a pre-marketing authorization regime and the issue is likely to dominate the debate.  This may reduce the opportunity for discussions on more technical – but not less important – issues.  Finally, it must also be noted that Mr. Peter LIESE, the rapporteur for the Regulation on IVDs, has not proposed such a pre-marketing authorization for IVDs.  We will provide update on the developments on this issue over the coming months.