EU Prioritizes Risk Management And Quality System Standards Now Legal Basis In Place
Ensuring key standards are available for manufacturers to demonstrate compliance with the MDR and IVDR is one of the top priorities for the European Commission after the summer break.
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Medtech companies accessing the EU market must be fully compliant with the new Medical Device Regulation by 26 May 2024 – but the regulatory structure is incomplete and companies also have the ongoing pandemic to contend with.
Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.
Manufacturers of COVID-19 tests may now have longer to comply with the IVD Regulation. But those from third countries need to be aware of the deadlines and hurdles ahead and act now.