Ann: CE Mark Update, page-287

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