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UK: MHRA updates regulatory status of equipment being used to help prevent coronavirus (COVID-19)

adminMTE_04792024-02-29T16:29:24+00:00May 20th, 2020|Categories: Compliance, Covid-19, UK|Tags: Covid-19, MHRA, Regulatory, UK|0 Comments

MHRA issued update to regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment).

Contents

  1. Antimicrobial hand sanitisers and gels
  2. Face masks
  3. Gloves
  4. Offers to supply or donate healthcare equipment to the NHS/healthcare providers
  5. Failure to comply with the relevant regulations
  6. Further information
  7. Information from other organisations
  8. Further MHRA advice

For more details, please see the original communication from MHRA.

Meditrial can help – Contact us for immediate support

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

  • Identify patients requiring follow-up
  • Conduct investigator and study nurse calls for training to address the situation
  • Obtain authorizations for decentralized data collection
  • Support to patients for alternative access to needed care
  • Prepare procedures and worksheets for remote collection of patient clinical data
  • Monitor work instructions and trainings for site support and remote monitoring
  • EDC and ePRO solutions to enable study continuity
  • Privacy protection measures

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