As a result of the scandal surrounding the breast implants from the French manufacturer PIP (Poly Implant Prothèses), which constituted a health hazard, the European Commission has issued instructions since 2012 with regard to enhanced monitoring activities within the framework of medical devices. This so-called "PIP action plan" includes targeted measures based on the existing regulations.
The core aspect consists of more stringent requirements for the monitoring of the Notified bodies. Notified bodies are the bodies – usually private companies – that check medical devices for their market conformity and issue a certificate for them. In addition to these more stringent requirements, the action plan also includes better international co-ordination of market monitoring and the more consistent implementation of measures.
Switzerland supports this procedure, which will ultimately increase patient safety. As a supervisory and enforcement authority, Swissmedic has initiated appropriate measures, and is in the process of implementing and enforcing them strictly. This results in more stringent requirements for the Swiss Notified bodies if they wish to maintain their services in the area of medical devices. The heads of the Swiss Notified bodies have been informed of the new requirements by Swissmedic, and compliance with them will be examined during designation or monitoring assessments on site.
Within the framework of its monitoring activities, Swissmedic has already detected irregularities and the need for improvements, and has initiated investigations. If the investigations reveal product-related risks, Swissmedic will initiate the necessary corrective measures and inform healthcare professionals and the public.
In the area of the regulation of medical devices, Swissmedic is integrated in the EU system and the European market, on the basis of the Bilateral Agreements I. In Switzerland, only those Notified bodies which are accredited by the State Secretariat for Economic Affairs (SECO) and by Swissmedic may test and certify medical devices.
Medical devices bearing the CE mark may be placed on the market in Switzerland and in the EU.
A further tightening of the requirements is presently under discussion, and particularly in the area of the clinical requirements for high-risk devices and in vitro diagnostics. The political process of modifying the EU legislation is currently under way. The new regulations will be applicable and binding at the earliest as of 2016.
Last updated: 27.01.2015