The European Union is often the first market for medical devices, given its relatively lenient policies. But those regulations are in the midst of a years-long process of change.
In order to restore public confidence after a scandal involving defective breast implants from the French company PIP, the European Commission (EC) issued an action plan in 2012 and drew up new medical device legislation. This week, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council of the EC declared the action plan a success and issued its vision for upcoming legislative changes.
Legislation is wending its way through an EC revision and adoption process that is expected to culminate in 2015, although new regulations aren't expected to be enforced until 2017 or 2018. Now EPSCO is calling on EU member states to adopt legislation before year end.
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| EU Commissioner for Consumer Policy Neven Mimica |
"Consumers are safer today than they were when the PIP scandal was discovered," said Neven Mimica, commissioner for consumer policy, in a statement. "Thanks to close cooperation between Member States and the European Commission, today's rules on medical devices are better enforced."
Added Mimica, "We succeeded in particular to tighten the control of notified bodies. Some key improvements, however, require a reinforced legal basis. This is why I called on the Member States to reach a political agreement before the end of this year in order to allow rapid adoption of this vital dossier."
In addition to the functioning of notified bodies, the action plan focused on market surveillance, coordination in the fields of vigilance, and communication and transparency.
In response to the action plan, EU member states have reassessed the qualifications and the scope of activities of their notified bodies; this resulted in corrective measures concerning the scope of activities in 8 countries. Voluntary joint audits of notified bodies have been carried out in 22 of 23 member countries; some of these resulted in operational changes. As part of the audits, certificates were reassessed, which sometimes resulted in suspensions or withdrawals. About 20 to 25 such audits are expected in 2014.
Notified bodies can also conduct unannounced audits of manufacturers. Member states are conducting monthly teleconferences to coordinate efforts, and incident data is being collected and analyzed.
EPSCO is looking for the new legislation to address a whole slew of issues including regulatory governance, transparency, obligations of notified bodies, clinical evaluation, risk classification of devices, the reporting of incidents, and the traceability of devices.
- here is the press release assessing the action plan
- and here are links to the EU medical device and in vitro diagnostic legislation