New rules for Medical Devices published by the EU - significantly tightened Controls planned

The PIP scandal (see GMP-News dated 01 February 2012) also has influenced the long planned revision of the rules for medical devices in Europe significantly. On 26 October 2012 the European Commission published proposals to ensure that especially patients can reap the benefits of safe, effective and innovative medical devices. But the proposals also address healthcare professionals working with medical devices. The proposals affect active and non-active medical devices as well as in vitro diagnostic medical devices.

The competent commissioner, at that time, Mr John Dalli, spoke about significantly tightened controls so as to ensure that only safe devices are placed on the market. The following are some of the main changes of the proposals:

• Stronger supervision of the notified bodies by national authorities; 
• Better coordination between national surveillance authorities; 
• More powers for notified bodies, including unannounced audits and sample testing;  
• Extended database on medical devices, providing the possibility for publicly available information; 
• Better traceability of medical devices with a Unique Device Identification System; 
• Stricter requirements for clinical evidence; 
• New classification of medical devices containing nano particles; 
• Revision of the conformity assessment of class III products by an EU body.

Interestingly, both documents are planned as regulations and no longer as directives. The final version of the regulation would be immediately applicable in all EU-Member States without the need for a prior transposition in national law. Adoption of the proposals is planned for 2014. Implementation would then take place step-by-step from 2015 - 2019.

For further information please see the press release of the EU "Safer, more effective and innovative medical devices" as well as the Proposals of the European Commission.