EU Parliament Adopts New Medical Device, IVD Regulations
The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations.
The new regulations, which include stricter premarket review of high-risk devices, strengthened designation criteria for notified bodies, improved traceability, as well as a risk-based classification system for IVDs, are the result of a multi-year negotiation process between the European Commission, Parliament and Council to address gaps in oversight that led to several device-related scandals.
Now that the legislative process has concluded, the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) are set to be formally published in the Official Journal of the European Union in May.
Following publication, the new regulations for medical devices will enter into force in three years, and in five years for IVDs.
The European Commission praised the Parliament's move to adopt the two regulations, which came nearly four and a half years after the Commission first proposed to replace the existing directives governing devices and IVDs.
"The Commission heartily welcomes the final compromise which contains a series of crucial improvements to the current system," said European Commissioner of Health and Food Safety Vytenis Andriukaitis.
During debate on the two regulations on Tuesday, MEP and rapporteur for medical devices Glenis Willmott said the new regulations will improve patient safety going forward.
"The metal-on-metal hip scandal highlighted weaknesses in the current system. So we've introduced much stricter requirements for the bodies that authorize medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorized," Willmott said.