Different regulatory framework for medical devices and drugs in the European Union: Impact on clinical research and health technology assessments.

Objectives: Understanding whether the regulatory framework in the European Union creates different standards for medical devices and drugs, assessing whether there is evidence on the impact of those standards on clinical and HTA research, and reflecting on findings in order to propose legislative changes for promoting a more efficient allocation of resources in the healthcare systems.

Methods: Reviewing and comparing the legal framework for the approval of medical devices and drugs in the EU, with a particular focus on the changes brought by Regulation (EU) 2017/745. Investigating the available information on manufacturer sponsored clinical studies and HTA-supported recommendations for medical devices and drugs.

Titanium dioxide nanotubes added to glass ionomer cements affect S. mutans viability and mechanisms of virulence.

This in vitro study evaluated the impact of TiO2 nanotubes (n-TiO2) incorporated into glass ionomer cement (GIC) on Streptococcus mutans (S. mutans) characteristics at cellular and molecular levels. n-TiO2, synthesized by the alkaline method (20 nm in size), was added to Ketac Molar EasyMix® at 0%, 3%, 5%, and 7% by weight.