EU’s MDCG Updates MDR Guidance

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU) has published an updated version of its guidance on the EU’s Medical Device Regulation ((EU) 2017/745, also known as the... Read More...

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the EU are now fully applicable to all devices. As of May 26, 2021, all new and existing medical devices must now conform ... Read More...

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).