The official guidance
for Medical Devices are known as MEDical DEVice documents.
This guidance covers a wide range of topics including;
Clinical assessment, rationale and evaluation, Safety and Post Market surveillance, Requirements of
conformity to relevant standards and legislation.
MEDDEVs are used by manufacturers, Notified Bodies, Competent Authorities and regulators such as the MHRA
to ensure the safe and regulated introduction of medical devices.
Not all MEDDEVs are applicable to a device or device type. It is between the manufacturer and the
regulator to agree which MEDDEVs are applicable prior to deployment of any device into a market.
LifeVac has worked with the MHRA to agree on which MEDDEVs were applicable.
Once these had been completed, they were subsequently agreed with the regulator.
Some of the principle
considerations have been outlined here, with a particular focus on those that
are queried most often.