The European Commission has drafted a series of new reforms that impact both in vitro diagnostics and medical devices. According to a press release by the European regulatory group, the new “Pip Action Plan” aims for greater control of its Notified Bodies. The draft of the new regulations is titled Regulation on Designation and Supervision of Notified Bodies and recommendations for Audits and Assessments.
The draft of these regulatory reforms was drawn up through the Standing Committee process that is described in Article 6 of AIMDD 30/385/EEC and Article 7 of MDD 93/42/EEC. Based on this, the changes detailed in this draft will come into play much faster than upcoming revisions that must go through a legislative process. Documents from the European Commission will probably be released before January, and all new changes will probably be implemented in the upcoming year.
The European Commission has received lots of criticism over its current Notified Bodies regulatory process. Competent Authorities demanded that the E.C. regulate activities by Notified Bodies to a high degree. The E.C.’s draft describes higher levels of regulatory oversight. This includes unannounced facility visits to both manufacturers and their subcontractors.
The European Association for Notified Bodies has also published a new version of its Code of Conduct.
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