By Stewart Eisenhart, Emergo Group
In addition to recent draft regulations concerning medical devices and in vitro diagnostics, the European Commission has drafted additional reforms ("PIP Action Plan") aimed specifically at greater control of Notified Bodies. The draft Regulation on Designation and Supervision of Notified Bodies and Recommendations for Audits and Assessments have been drawn-up by means of the Standing Committee-mechanism described in Article 7 of the MDD 93/42/EEC (and Article 6 of the AIMDD 90/385/EEC). Therefore, these changes are expected much sooner than the impending legislative revisions. The Commission documents are expected to be released before the end of 2012 and the changes will likely be implemented as soon as 2013.
These Commission documents follow long-standing criticism of the current Notified Body system. Competent Authorities have demanded that the Commission ensure that Notified Body activities are held to a high standard and are supervised effectively. The Commission’s draft documents describe heavier regulatory burdens, such as unannounced visits to manufacturers and their critical subcontractors (which of course is a provision of the proposed regulation). While one of the Commission documents is advanced as a recommendation, it is fully expected that the Member States will enforce this guidance. It is also expected that Notified Bodies will be required to sample and test devices according to device specifications. The Commission documents will prepare Notified Bodies and manufacturers for increased regulatory scrutiny and align the regulatory landscape with forthcoming changes in the EU medical device market.
Concurrently, Team-NB (the European Association for Notified Bodies) has published an updated version of their Code of Conduct (version 3) which similarly includes unannounced audits. This section is "applicable directly," though it remains unclear who will bear the cost of such interventions and whether the contracts between Notified Bodies and manufacturers will need to be revised. According to the third version, the frequency of unannounced visits will depend on device classification, non-compliance, or non-conformities. The visits will take place at minimum every three years. Manufacturers will also need to develop SOPs to address these visits. The impending shift towards increased Notified Body supervision is an effort to address concerns about Notified Bodies, learn from the PIP scandal, and to ensure patient safety.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.