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Beginning Sept. 1, companies that put their names on devices made by other companies must have their quality management systems (QMS) audited and full technical documentation reviewed by notified bodies, says new guidance from the UK’s MHRA. Read More
The European Union’s new Medical Device Regulation (MDR) will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures. Read More
Australia’s Therapeutic Goods Administration (TGA) is proposing to review products currently classified as Class I medical devices to see if they should be reclassified as consumer goods. Read More
The UK’s Medicines and Health products Regulatory Agency (MHRA) has issued new guidance on how to register a device manufacturer or authorized representative with the agency in order to sell devices and IVDs. Read More
The FDA is delaying UDI rule requirements for soft contact lenses until one year after it resolves a technical problem — and the agency has granted a third extension for labelers of the lenses. Read More