Mar 25, 2020

The United Kingdom has experienced several regulatory updates, as the Medicines and Healthcare products Regulatory Agency (MHRA) releases new documents and announces changes to standard practice designed to help combat spread of the COVID-19 pandemic.

Guidance establishes standards for emergency ventilators

The agency has published a new guidance, Specification for Rapidly Manufactured Ventilator System (RMVS). This document specifies the minimum clinically acceptable performance requirements for ventilators during the COVID-19 pandemic. The standards employed here draw on the advice of anesthesia and intensive care medical professionals and medical device regulators. The ventilators covered here are designed to treat acute respiratory distress syndrome (ARDS) and are anticipated to be needed in large quantities as more people fall ill.

Form enables regulatory check for manufacturers of coronavirus test kits

A new form issued by the MHRA allows manufacturers of professional-use test kits to confirm that their products are legal to put on the UK market. The form must be completed and submitted to the email address given in the announcement, and device performance data must also be supplied. Further specifications for test kits are being developed and will be published as soon as they are available. The accompanying notice also reiterates that there are no CE marked coronavirus test kits approved for home use.

Learn how medical device markets are reacting to COVID-19.

MHRA adjusts day-to-day practices under pandemic conditions

The agency further announced that most of its employees will be working from home until further notice. Additionally, Good Practice Inspections will be deferred until further notice. Inspections of certain facilities linked to the COVID-19 response will be prioritized.

As around the world, this situation is developing rapidly, and further developments in the UK regulatory system will be noted here.

Related UK medical device regulatory resources from Emergo by UL:

  • Brexit transition consulting for medical device and IVD companies
  • Whitepaper: How medical device companies can prepare for a no-deal Brexit
  • Whitepaper: How to select or change your Notified Body
  • Webinar: Impact of a no-deal Brexit

 

Author

  • Timothy Herr

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