The new draft EU regulations on medical devices and in vitro diagnostic medical devices were published on 26th September 2012 with a stated aim to ‘achieve a suitable, robust, transparent and sustainable regulatory framework’ for medical devices and in vitro devices. These seek to replace three existing directives dealing with medical devices and in vitro diagnostic devices which were agreed in the 1990’s. The RCN has developed a position statement on these proposals which is attached and focuses on:
- Extending the scope of the legislation to include invasive and implantable devices without a medical purpose (within proposed medical devices legislation)
- Extending the definition of an in vitro device to include genetic tests • Clarifying that a device sold over the internet for diagnostic or therapeutic purposes must comply with both of the proposed regulations
- Clarifying existing rules on self testing and signposting to healthcare professionals
- Requiring all manufacturers of implantable devices to provide an ‘implant card’ for users.
- Establishing a system of unique device identification (UDI), a central database to underpin the reporting system and a requirement on manufacturers of certain products to produce a summary of safety and clinical performance of the device.
- Requiring competent authorities to encourage healthcare professional to report nationally and to develop a standard form for healthcare professionals when they report This position statement will help inform the RCN response to the UK consultation on its position.