Important Update: MDCG 2020-16 Rev.3 Guidance on IVD Classification RulesImportant Update: MDCG 2020-16 Rev.3 Guidance on IVD Classification Rules
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
