The European Union (EU) was established with the objective of setting up a single market to facilitate trade, allowing it to happen freely within the member states participating in the EU. For this, the products needed to be standardized and regulations needed to be harmonized across the member states. Harmonized standards were developed for products, processes, systems, and services carrying guidance, requirements, and recommendations from globally recognized standards like ISO and IEC.
The European Commission requests the European Standards Organisations to create different standards to support manufacturers and other stakeholders, such as other economic operators or conformity assessment bodies. This is done to demonstrate that products, services, or processes conform to their relevant EU legislations. The Official Journal of the European Union (OJEU) officially declares the release of a harmonized standard, after which, they can be applied.
A MDCG (Medical Device Coordination Group) guidance document – MDCG -2021-5: “Guidance on Standardisation for Medical Devices” was published in April 2021, which provides guidance on varying aspects for the various existing directives as well as the more recently introduced regulations like the MDR and IVDR.