EU Medical Device Regulation Module

The EU Medical Device Regulation Module helps companies meet their obligations under Section 10.4 of the European Union (EU) Medical Device Regulation (MDR) by solving their most challenging data-related concerns and helping to identify and mitigate supply chain risks. The module automatically gathers, validates and stores supply chain data pertaining to substances in scope of the EU MDR. This data can be leveraged to meet deadlines for product certification and approval, protect market access and mitigate the risk of fines.

By enabling suppliers to upload substance declarations and supporting documentation necessary for compliance with IEC 63000 Standards for technical file creation, Assent’s integrated Supplier Portal allows companies to redirect resources dedicated to manual supplier engagement processes toward core initiatives. Supply chain communications are streamlined with the Campaign Manager, promoting fast and efficient supplier engagement, while tracking the success of outreach campaigns.

The EU Medical Device Regulation Module also offers convenient integration with valuable products like Assent University, which help suppliers work proactively to identify risk and remain educated about their EU MDR requirements, minimizing the risks associated with non-compliance. This module supports compliance with data collection requirements for substances defined in Section 10.4.1 A and B, as per the Medical Device Regulation (EU) 2017/745, as well as the In-Vitro Diagnostic Devices Regulation (EU) 2017/746.

The EU Medical Device Regulation Module ensures companies remain up to date with changes to the EU MDR and IVDR with timely restricted substance alerts and automated data collection and validation. Companies are able to assess and address supply chain risk and gaps in data to proactively maintain compliance with EU MDR.