Medical Devices

Following the PIP breast implant scandal in 2010 the European Commission signaled in September 2012 its intention to increase the regulation of medical devices in the EU to increase consumer and clinician confidence in the safety of medical devices. Measures include strengthening the supervision of the notified bodies that carry out the pre-market assessment of medical devices; expanding and increasing the transparency of the European database on medical devices and the requirement for medical devices to carry a unique device identifier (UDI).

The HDA has been working closely with the European Healthcare Distribution Association (GIRP) to explain the potential impact to European and national regulators, such as the MHRA; and HDA has been demonstrating the implications for daily operations in the supply chain. We are pleased to report that the final approved legislation, published by the EU in the summer of 2016, mandates a ‘risk-based’ pragmatic approach to the requirements for wholesalers.