UK Allows Non-CE-Marked Devices On Market Under Exceptional Use Route

The UK government has launched an initiative to get non-medtech manufacturers involved in the production of ventilators. But it looks like they will be scrapped after the emergency has passed.

Rules

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a document which relaxes standards for ventilator producers as part of the government’s response to COVID-19.

When the current emergency has passed, ventilators produced under the exceptional use emergency route “will NOT be usable for routine care unless they have been CE marked through the [UK]...

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