The European Commission plans to enhance the traceability of medical devices and monitoring of notification bodies to prevent the placing on the market of defective devices, like the adulterated breast implants produced by the firm PIP. On the other hand, the future revision of Directive 93/42/EEC will not propose specific authorisation for the placing of such products on the market. This is the gist of what emerged during an airing of views by Commission representatives and members of the EP's Committee on Environment and Public Health (ENVI), on 24 January. The discussions resulted from an oral question (2012/01) by Linda McAvan (S&D, UK) on the specific case of PIP and the upcoming revision of the current legal framework.
NO SPECIFIC AUTHORISATION
Asked about the content of the future proposal, Paola Testori Coggi, director-general for health and consumers at the European Commission (DG Sanco), said that the main changes concern traceability and the control of medical devices. Traceability will be assured from the place of production up to the person using the device.
The Commission is considering setting up a unique identifier and a complete database for the entire production chain. It will also propose to tighten market surveillance and improve monitoring of notification bodies in charge of issuing conformity certificates to manufacturers.
Testori Coggi expressed support for the idea of making unannounced inspections the general rule to keep companies from preparing for inspectors' visits with the aim of deceiving them, as happened in the PIP case. She refused to comment on suggestions by MEPs in favour of a European body overseeing the 70 to 80 notification bodies that currently exist across Europe. She also explicitly refused to submit medical devices to authorisation for placing on the market, as is already the case for medicines, arguing that "national authorities must...