In light of the recent PIP breast implant scandal, more monitoring of certification bodies is requested under the new proposed Medical Devices Directive to improve patient safety.
Until now, independent certification bodies, approved by Member States, provided authorisation to medical devices coming into the market.
Some MEPs are calling for a centralised EU authorisation of medical devices, however the Commission will not propose this for the Medical Devices Directive (MDD). Eucomed, which represents the medical technology industry in Europe, stressed that with centralisation, patient safety and the speed at which patients receive urgently needed medical devices are compromised.
The revision of MDD aims at establishing a centralised oversight system to ensure that certification bodies are operating appropriately, rather than there being the need to overhaul the existing system.
The MDD file is currently under discussion in the European Commission. On 26 September, the European Commission proposed new legislative rules.
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