Following the aftermath of the PIP scandal where industrial silicone was found to have been, fraudulently, used in the manufacture of breast implants, combined with some other high profile device failures, the European Commission, on the 26th September 2012, released its planned proposal for future regulations for Medical Devices. The target release date for these regulations is 2014 to gradually come into effect between 2015 – 2019.
Some of the key elements of the proposals are:
- The MDD (directive) will take the form of a regulation
- Additional Notified Body powers, including unannounced visits to manufacturers
- Stronger National Authority supervision of Notified Bodies
- Extended database on medical devices (Eudamed)
- Clinical evaluation throughout the lifecycle of the device including pre-market data
- Better traceability of medical devices (UDI)
- Improved Post Market Surveillance (PMS) and Vigilance
- Better co-ordination between National Regulators
- A requirement for medical device manufacturers to have a ‘qualified person’ to ensure compliance
Further information is available via the links below:
http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm