Update on EU Regulations on Medical Devices
In September 2012, the EU Commission submitted its proposal for new EU Regulations on medical devices and in vitro diagnostics – followed by extensive discussions amongst interest groups and associations in order to mitigate detrimental effects on the industry sector.
The on-going legislative process is still complicated by different perceptions in the member states and, therefore, completion of interstate coordination and definition of a common position of the member states concerning the legislative proposals by the EU Commission and the EU Parliament cannot be predicted at present. In consequence, commencement of negotiations between Commission, Parliament and Council (“trilogue procedure”) is not expected before autumn 2014, entry into force of the Regulations will most likely not take place before 2017. Once in force, the Regulations will, however, be directly applicable in member states without the need for implementation on national level.
The draft Regulations include measures of EU-wide standardisation, e.g. requirements for the labelling of medical devices and technical documentation, classification standards and the requirement to implement a unique device identification system. Some of these measures are still subject to controversial discussion (e.g. the proposals for the reprocessing of medical devices). On the contrary, the measures meanwhile adopted by the EU Commission on 24 September 2013 to improve consumer safety by implementing stricter criteria for nomination and supervision of admission organs (“notified bodies”) have already been widely acknowledged by experts as appropriate means to reduce the amount of notified bodies.