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A notified body conducts conformity assessments allowing manufacturers to affix the CE mark to their devices and place them on the European market.
There is a general consent on the need of stricter rules to regulate the 80 notified bodies for medical devices in the European Union.
It is based on interviews with 42,000 women across the EU, who were asked about their experiences of physical, sexual and psychological violence, including incidents of intimate partner violence (‘domestic violence’).
The survey also included questions on stalking, sexual harassment, and the role played by new technologies in women’s experiences of abuse.
It argued that a complicated scrutiny process with a case-by-case centralized pre-marketing authorization system would primarily create heavy bureaucracy, high costs and eventually result in delay of innovation.
Ms Roth-Behrendt (S&D), the German Member of European Parliament responsible for the medical devices dossier expressed some disappointment that a system advocating preliminary authorisation for high risk products was not appreciated in this first battle on a new legislation.
So far, the European Union is operating under a regulatory framework for medical devices established by three directives in the 1990s.In September last year, the proposals for medical devices and IVDs were published: The European Commission proposed a Regulation on medical devices to replace Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices.At the same time, also a proposal for a Regulation on in vitro diagnostic medical devices to replace Directive 98/79/EC regarding in vitro diagnostic medical devices was published.It was about time to adapt the rules to technological progress, also with a view to reach a more harmonized system in a single market.Then the PIP scandal added pressure on the European Commission to quickly table plans for new legislation: French breast implant manufacturer Poly Implant Prothèse, S. (PIP) used industrial gel in the production of breast implants instead of medically approved gel.
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