UK Regulator Puts Energies Into COVID-19 While Other Services May Take Longer
Executive Summary
With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.
You may also be interested in...
UK Shares How Its Medtech Regs Already Diverge From The EU: COVID-19 Marks The Start
The MHRA has updated its guidance on regulatory flexibilities for medical devices and medicinal products resulting from COVID-19 to highlight how its approach differs from the EU.
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.
No Quick Fix When It Comes To EU Medtech Notified Body Designations
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.