While the European Union is undergoing major reforms to its regulation of medical devices, diagnostics, and drugs, an industry representative said there are still challenges and that more actions to streamline regulations and reduce the burden on industry are needed.
During the plenary session at the DIA-RAPS Combination Products in the EU conference, a panel representing the healthcare product industry, notified bodies, and regulators discussed upcoming legislative reforms, such as the EU General Pharmaceutical Legislation (GPL), the Biotech Act, and the planned revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)...[RAPS]
