Out-Law / Your Daily Need-To-Know

UK concerned that reforms to medical device regulations could increase NHS costs

07 Jan 2016, 4:04 pm

The UK government is concerned that reforms to EU rules on medical devices could lead to increased costs for the NHS but is hopeful that those concerns will be addressed during final negotiations on the new laws, according to a parliamentary committee.

The European Parliament, Council of Ministers and European Commission are in the process of finalising a new Medical Devices Regulation and In-Vitro Medical Devices Regulation.

Those trilogue negotiations are expected to be concluded by June, a summary (5-page / 127KB PDF) of a meeting held on 6 December by the European Scrutiny Committee said. The summary noted concerns the UK government has with two aspects of the proposed reforms.

"The government expresses cautious optimism that a satisfactory outcome on the UK’s key negotiating objectives is within reach," the meeting summary note said. "These focus on two concerns: the possible introduction of additional pre-market scrutiny of higher risk medical devices by a central committee of member state experts, and the proposed removal of an existing exemption for 'in house' devices manufactured and used within the same health institution."

"The government considers that additional pre-market scrutiny would be ineffective, overly bureaucratic and delay patient access to life-changing medical technologies, whilst the removal of the exemption for 'in house' devices would substantially increase costs within the NHS," it said.

Under plans backed by the Council of Ministers, medical device manufacturers would be required to "plan, conduct and document a clinical evaluation" of their products to demonstrate they meet safety and performance requirements before those devices can be put on the market or used in the EU.

Manufacturers would in some cases also have to ensure their devices were assessed for conformity with the new rules by independent 'notified bodies', whose activities would be overseen by regulators, before the devices could be sold or used in the trading bloc.

In addition, medical device manufacturers would also have to put in place a "post-market surveillance system" (PMSS) to ensure that faults with their devices can be identified and corrected after they have been put on the market.