The Medical Device Coordination Group (MDCG) has released an updated version of the Guidance on Classification Rules for in vitro Diagnostic Medical Devices (IVDs) under Regulation (EU) 2017/746. This revised guidance, MDCG 2020-16 Rev.3, provides clarifications and updates to assist manufacturers in correctly classifying their IVDs.
Key Changes in MDCG 2020-16 Rev.3:
– Enhanced clarity on classification rules: The guidance provides more detailed explanations and examples to help manufacturers determine the appropriate risk class for their IVDs.
– Updated information on borderline and classification issues: The guidance addresses recent developments and clarifications regarding borderline cases and classification disputes.
– Improved guidance on the application of Annex VIII: The guidance provides more specific instructions on how to apply the Annex VIII classification rules to various IVD types.
Why is this update important?
– Accurate classification is crucial: Proper classification ensures that IVDs undergo the appropriate conformity assessment procedures and are subject to the correct regulatory requirements.
– Reduced risk of non-compliance: By following the updated guidance, manufacturers can minimize the risk of non-compliance and potential market restrictions.
– Facilitated market access: Accurate classification can expedite the market authorization process for IVDs.
The Medical Devices Regulatory — support unit (MDRu) of Instituto Pedro Nunes is here to assist you with understanding and applying the MDCG 2020-16 Rev.3 guidance. Feel free to contact us for further information: https://lnkd.in/dreiWTp7