Written by Gregor Erbach
In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person’s health. The industry employs about 75 000 people in Europe, and generates some €11 billion in revenue per year.
In September 2012, the European Commission (EC) published a proposal for a new regulation on in vitro diagnostic medical devices, as part of a larger legislative package on medical devices. The proposed legislation aims at enhancing safety, traceability and transparency without inhibiting innovation.
In April 2014, the European Parliament (EP) amended the legislative proposals to strengthen the rights of patients and consumers and take better into account the needs of small and medium-sized enterprises (SMEs).
Some stakeholders consider that a provision for mandatory genetic counselling interferes with the practice of medicine in Member States and violates the subsidiarity principle. Device manufacturers warn that the proposed three-year transition period may be too tight.