Manual on Borderline and Classification for Medical Devices under Regulation (EU)
In September 2022 the European Commission published version 1 of the manual on borderline and classification for medical devices.
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Accelerating Clinical Trials in the EU (ACT EU) Multi-Annual Workplan 2022-2026
On 2 September the EMA published the updated ACT EU multi-annual workplan.
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Updated IRIS Guide for Applicants
On 5 September the EMA published version 2.12 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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Swissmedic Online Information Event: New Regulations on In Vitro Diagnostic Medical Devices
On 5 September Swissmedic announced an online information event for new regulations on in vitro diagnostic medical devices.
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General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products
On 7 September 2022 the FDA published draft guidance on clinical pharmacology considerations for pediatric studies.
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