New MDCG 2024-8 Rev. 1 Document: Key Updates for Conformity Assessment under the IVDR

The Medical Device Coordination Group (MDCG) has released Revision 1 of the MDCG 2024-8 document, introducing significant changes to the preliminary assessment review template for in vitro diagnostic medical devices (IVDR) under Regulation (EU) 2017/746. This update, published in January 2025, aims to streamline and enhance the conformity processes for notified bodies and designating authorities.

One notable update is the removal of Section G.4, which was deemed redundant in its application by notified bodies. This change underscores MDCG’s commitment to eliminating overlaps and making procedures more efficient. The revised document also provides updated guidance on organizational, technical, and quality management requirements that notified bodies must fulfil to ensure regulatory compliance.

At Smart MDR, we recognize the critical importance of staying up to date with these changes to help our partners navigate the complexities of regulatory frameworks. The MDCG 2024-8 Rev. 1 is a vital tool for ensuring that conformity assessments are conducted rigorously and in line with European Union standards.

Access the full document and discover how it could impact your certification processes. Click the document below for more details.