Technical Takeaways The afternoon conference session focused on technical issues, and participant

Technical Takeaways

The afternoon conference session focused on technical issues, and participants emphasized the need for a “robust, transparent and proportionate” regulatory structure to support development of innovative medical technologies. Paola Testori Coggi, European Commission Director General, Health and Consumers, opened the session by telling attendees that the discussion was just one of many that must take place before the Medical Devices Directive can be revised. There were various presentations from different entities who had been invited to share their perspectives. All participants who wanted to provide verbal comment were permitted to do so. And of course, as with all EU Commission-hosted meetings, there were translators there to help speakers voice their opinions in their language of choice.

Perhaps the most significant suggestions were proposals for more extensive cooperation between national authorities during pre- and post-market phases of medical device commercialization, specifically by establishing greater uniformity of conformity assessments among Notified Bodies. In addition, participants said Notified Bodies should assess only those devices in which they have appropriate competence and expertise.

To boost post-market device safety, participants urged regulators to centralize the notification and analysis of serious incidents to facilitate EU-wide responses to such events and protect public safety.

Among participants’ other major recommendations were the formation of a centralized public database to contain information on medical devices, manufacturers and authorized representatives, clinical investigations and corrective actions. The database also would provide tracing capabilities of devices for safety purposes. It is recognized that Competent Authority use of Eudamed is compulsory beginning this month; however, access to Eduamed is limited and will not publicly be accessible.

A more extensive collection of clinical data from pre-market studies and post-market surveillances also was advocated to support clinical evidence required for regulatory as well as reimbursement purposes.

Given the budget difficulties afflicting some EU member states, however, the costs and resources necessary to set up such a regulatory infrastructure—not to mention maintain adequate healthcare delivery systems—are not insubstantial. Pooling resources among multiple national competent authorities as well as setting up funding mechanisms on national levels could address resourcing challenges, participants suggested.

Finally, recent published reports about the differences between the EU and U.S. medical device regulatory systems were mentioned (faithful readers might remember reading about those differences in this column just last month).