Current Issues

Following the PIP breast implant scandal in 2010, the European Commission signalled 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 included 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 worked closely with the European Healthcare Distribution Association (GIRP) to explain the potential implications for daily operations in the supply chain to European and national regulators, such as the MHRA. We were pleased to report that the final approved legislation, published by the EU in the summer of 2016, mandated a ‘risk-based’ pragmatic approach to the requirements for wholesalers.

Medical devices continue to be at the forefront of the sector’s agenda, even more so in the context of the UK’s exit from the EU. Following the introduction of the Medicines and Medical Devices Bill 2019-21 into the House of Commons at the beginning of 2020, its importance in the context of the future of UK regulation has been recognised by industry leaders up and down the supply chain. The Bill addresses safety and regulation of medical devices and medicines, and aims to provide a framework for innovation in post-Brexit UK. Further to this, the Brexit deal agreed to at the end of 2020 contains several provisions to ensure that the UK and EU are able to work together to remove unsafe devices from their markets, that medical devices are effectively labelled, and that there is ongoing opportunity for further collaboration.