In a summary of the state of play by Global Medical Device consultant Emergo Group, European Health and Consumer Policy Commissioner John Dalli has reportedly demanded coordinated efforts at national levels to ensure full implementation and enforcement of existing medical device legislation.
John Dalli’s aim is to guarantee safety and improve patient confidence in the EU regulatory system, something which has been questioned in the past year with high profile medical device issues hitting the headlines and often bringing into question the regulatory control exerted over these devices, most specifically in the EU.
- Verification of notified body designations to evaluate whether these entities are truly designated only for assessment of medical devices and technologies.
- Ensuring that Notified Bodies fully leverage their authority laid out in conformity assessments, including their power to conduct unannounced inspections.
- Reinforcing market surveillance processes by national regulators, especially regarding spot checks of some devices.
- Vigilance system functions must also be improved via granting Notified Bodies systemic access to adverse event reports and urging health care providers and patients to report adverse events to authorities.
- Supporting development of tools to enhance traceability of medical devices in the EU, and tools such as the Unique Device Identification system for monitoring long-term safety and performance of devices.
Results of a stress test being conducted to address any weaknesses in the EU system illustrated by the PIP incident will impact ongoing work to revise the EU’s Medical Devices legislation, according to a European Commission press release.
European medical device industry trade association Eucomed has officially expressed support for Dalli’s recommendations, and has added a few of its own as we have reported extensively on our own pages, including utilizing “only the best” Notified Bodies, developing a single approach to vigilance and market surveillance, and strengthening harmonized standards used in the EU. Furthermore, Eucomed recommends more consistent guideline implementation, added transparency and a more integrated regulatory approach.
Emergo concludes; “Whether the PIP controversy significantly impacts how Europe’s Medical Device Directives are revised remains to be seen. Reactions among member states so far do not bode necessarily well for a more unified approach, however; French authorities, for example, have initially taken a much more aggressive approach to the problem than their British counterparts.”
We’ve spoken about the need for some simple measures such as the unannounced spot-checks detailed already. However we’re not fans of knee jerk reactions of the kind demonstrated so far by the French authorities and indeed question whether for example the desperate charge to announce government funded replacement of PIP implants was particularly helpful or indeed based on much scientific evidence. What’s certainly true is that Medical Device Directive reforms are overdue, but we’re nervous about adopting a regime which stifles innovation, especially measures which are brought in to guard against recurrence of problems without actually having any likelihood of doing so, while simultaneously adding a layer of expense and rigour to the approval process for products which are already subject to what appear to us to be reasonable control.
Source: Emergo, European Commission