Overview report of a series of voluntary joint assessments of notified bodies
After the breast implant scandal broke in Europe in late 2011 both the Commission, the EU Member States and EFTA and EEA countries realised that there was an urgent need to investigate what had gone wrong and to restore confidence in the regulation of medical devices.
One of the actions led to the vetting of notified bodies responsible for conformity assessment of medical devices. The Commission took the lead in organising joint assessments of notified bodies, with the agreement of both the national authorities and the notified bodies in question. This report presents the outcome of 25 such joint assessments carried out in 23 countries in 2013 and 2014.
It identifies common problems in the performance of both notified bodies and the national authorities responsible for their surveillance and monitoring. National authorities were requested to address these deficiencies, improve their monitoring of notified bodies and ensure that these do their job properly. In some cases, the joint assessments led to restrictions on notified bodies, ranging from compulsory reassessment of medical devices already on the market, to the termination of some notified bodies’ activities.
The report also identifies best practices in the performance of national authorities and these have been shared among all of the EU authorities. Overall, these joint assessments have resulted in an improvement in the performance of notified bodies and their respective national authorities.
The exercise has also laid the foundations for the introduction of a new and more comprehensive system for the assessment of notified bodies in the EU and has also provided valuable input to the ongoing negotiations in the European Parliament and Council on a new regulatory framework for medical devices in general.
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