Good work Merlin88 although FDA has its own pathway and the CE...

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 nutshell

The 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