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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
The FDA’s Medical Devices Advisory Committee recommended in a March 23 meeting that patients have their vision evaluated before periocular treatment with dermal fillers. 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
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 should refine its processes for breakthrough device designation to better reflect the risks and benefits associated with such devices, researchers from three prominent medical schools advised in a New England Journal of Medicine article. Read More