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Focus on Regulation

Tag Archives: MHRA guidance

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”). The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR

The MHRA issues new guidance concerning common issues in clinical trial applications

On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of Clinical Trial Authorisation (CTA) applications. The Guidance is intended to assist clinical trial sponsors in identifying avoidable delays, to the benefit of