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MHRA revises clinical investigation guidance

  • Posted by: inetika
  • Category: GLOBAL NEWS

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated 2013 clinical investigation guidance to better reflect the forthcoming Medical Device Regulation (MDR, 2017/745).

The guidance introduces the need for ensuring that the “anticipated benefits to the patients enrolled in the clinical trial justify the foreseeable risks” in accordance with Article 62 of MDR, and that sufficient data must be submitted for review to “provide assurance that all necessary toxicological risks have been appropriately considered”.

Other revisions reflect not only MDR requirements relating to toxicological risk assessment, but also take into account the 2018 edition of ISO 10993-1, especially as it relates to the assessment of implants and blood contacting devices.

Copies of the revised guidance can be downloaded from here.

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