Good work Merlin88 although FDA has its own pathway and the CE mark would has little bearing on it.
BSI and OSL would be impacted by 4 new regulations highlighted below.European Commission > Internal Market, Industry, Entrepreneurship and SMEs > Sectors > Medical Devices > New regulations
The new regulations in a nutshellThe new regulations contain a series of extremely important improvements to modernise the current system. Among them are
- stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
- reinforcement of the criteria for designation and processes for oversight of notified bodies
- inclusion of certain aesthetic devicesthat present the same characteristics and risk profile as analogous medical devices under the scope of the regulations
- anew risk classification system forin vitrodiagnostic medical devicesin line with international guidance
- improved transparencythrough a comprehensive EU database on medical devices and a device traceability system based on unique device identification
- introduction of an ‘implant card’for patients containing information about implanted medical devices
- reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-centre clinical investigations
- strengthening of post-market surveillance requirements for manufacturers
- improved coordination mechanismsbetween EU countries in the fields of vigilance and market surveillance
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Good work Merlin88 although FDA has its own pathway and the CE...
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