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Devicemakers will need to submit applications to the TGA to show that risk mitigation strategies are in place and that the IVDs comply with performance requirements. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released a Q&A document to help answer questions relating to custom-made devices covered under the EU Medical Device Regulation (MDR). Read More
EU member states have agreed to start negotiations on a proposal that could lead to joint health technology assessments (HTAs) in the bloc, but MedTech Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are worried about some elements of the proposal. Read More
Australia’s Therapeutic Goods Administration (TGA) has outlined its expectations for developers of in vitro diagnostic (IVD) self-tests for infectious diseases like influenza, hepatitis B and hepatitis C, chlamydia, gonorrhea and syphilis. Read More
The FDA said it is investigating numerous medical device reports (MDRs) of patient infections and contamination associated with reprocessed urological endoscopes, including three reported deaths outside the United States. Read More
China’s National Medical Products Administration will allow “versatile” clinical evidence to demonstrate safety and effectiveness, according to attorneys at the law firm Ropes & Gray. Read More
Australia’s Therapeutic Goods Administration (TGA) has outlined its expectations for developers of in vitro diagnostic (IVD) self-tests for infectious diseases like influenza, hepatitis B and hepatitis C, chlamydia, gonorrhea and syphilis. Read More
The EU’s Medical Device Coordination Group (MDCG) has clarified minimum performance requirements for devices intended to detect antibodies against the SARS-CoV-2 virus in a new guidance. Read More
The FDA is warning devicemakers that have been touting phony FDA registration certificates that give the false impression that their products have been cleared by the agency. Read More
As part of postmarket surveillance, devicemakers should continuously monitor the performance of their devices, including for new potentially cross-reacting agents that could lead to inaccurate results, the group said. Read More