To place medical electrical equipment onto the European or Great Britain market manufacturers must obtain CE or UKCA Certification.
Compliance with the state of art standards is the preferred route to demonstrate compliance with the applicable General Safety and Performance Requirements (GSPRs) of the Medical Devices Regulation (MDR) (EU) 2017/745 or with the Essential Requirements (ER) of the UK Regulation. As few standards are currently harmonized to the regulations, when being assessed against the Regulation, understanding and meeting the requirements of EN 60601 is crucial. EN 60601 represents a state-of-the-art standard and can therefore be applied to show conformity with the applicable Regulations requirements.
