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To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway in a [...]

The published version 1 of the Manual on borderline and classification for Medical Devices under Regulation (EU) 2017/745 on medical [...]

On September 28, 2022, the two decrees for the adaptation of Italian regulations to the provisions of MDR (EU) 2017/745 [...]

Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, [...]

Through the document Clinical evidence guidelines for Medical Devices published last June, TGA has finally made available the most significant [...]

In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory Agency) is [...]