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MDCG Recent Guidance on MDR, IVDR



The European Commission’s Medical Device Coordinating Group (MDCG) recently issued new guidance which explains the role of safety and performance standards under current and incoming Medical Device Regulation (MDR) and In-vitro Medical Devices Regulation (IVDR).

Recent guidance from MDCG answers the questions related to use of harmonised standards issued under existing Directives along with answers to regulation standardisation requests coming into effect from May 2021 (MDR) and May 2022 (IVDR).

This release lays down recommendations to the manufacturers regarding the importance of harmonised European Standards (hENs).

“This particular legal status of hENs cited in the OJEU (Official Journal of the European Union) generally allows manufacturers and other sectorial actors (including notified bodies and national competent authorities) to make easier, quicker and less burdensome the processes related to conformity assessment procedures, affixing of the CE marking and placing on the market, market surveillance, etc.,” states the new guidance.

Although the use of hENs for the purpose of obtaining CE Marking and demonstrating compliance is voluntary by manufacturers, hENs help confer a “presumption of conformity” to legal requirements necessary for certification and commercialization in Europe.

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