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Devicemakers should also submit device classification applications to seek classification determination opinions for any new devices not covered by the catalogue or notices. Read More
The International Medical Device Regulators Forum agreed to a new work item proposal to develop technical documents that support a harmonized approach to defining devices manufactured for individual patients. Read More
The letter urges the leaders to adopt the EU’s new regulations covering medical devices and IVDs to encourage global harmonization and to keep EU-wide networks strong. Read More
The UK’s Medicines and Healthcare products Regulatory Agency plans on issuing guidance on co-developing medicines and IVDs in the near future. Read More
The UK’s Medicines and Healthcare products Regulatory Agency published new guidance on human factors and usability engineering for medical device manufacturers — pulling back the curtain on the UK’s regulatory structure, and showing how various usability engineering strategies stack up against each other. Read More