MEDICAL DEVICES: new regulations approved by the EU Parliament
30/10/2013
The European Parliament has recently approved (with some modifications) the two regulation drafts on medical devices and on in vitro diagnostic. The approved standards are intended to ensure the transparency of information for both patients and medical staff and to enhance the traceability rules, without creating additional burdens for minor innovator manufacturers. Much attention to the procedures for inspection and certification. In the next weeks, the negotiations with the Council on both proposals will take place.