ivdr

EU Commission Proposes More Time for Compliance with IVDR

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its...

EU Commission Proposes to Extend MDR/IVDR Deadlines

The Commission of the European Union (EU) has proposed extending the transition period for...

EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain...

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...

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EU Commission Proposes Codes for Medical Devices Under MDR/IVDR

The Commission of the European Union (EU) has issued a detailed list of proposed codes to be used by EU Notified Bodies in the categorization and assessment of medical devices under the EU’s Medical Device Regulation (Regulation (EU) 2017/745, also known as the MDR) and the In Vitro Diagnostic Device Regulation (Regulation (EU) 2017/746, also known as the IVDR).

The EU’s MDR and IVDR Achieve Final Approval

The wait is nearly over for the official publication of the European Union’s (EU)...

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