(PMS) Post-Market Surveillance for medical devices is a regulatory requirement. It is mandatory in global markets including the United States and European Union. PMS comprises of activities that relies on data gathering....

After separating itself from the European Union, Great Britain introduced UKCA Mark mandatory for medical devices to conform to the new regulations. Any manufacturer who wishes to enter into the UK market...

Any manufacturer who intends to market their medical devices, including in-vitro diagnostics in the UK, must register medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) before placing them into...

European Union Medical Device RegulationIntroduction European Union Medical Devices Regulation (EU MDR)Reasons for replacing Medical Device Directives (MDD)Medical Device ClassificationScope of EU MDRChallenges in implementing the MDREU MDR ComplianceReference Introduction European Union...