• EU Medical Device Regulation Module

    Identify Risks & Remain Compliant

Navigating the Compliance Landscape: Medical Devices
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The 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.

How Assent Supports
Compliance With the In-Vitro
Diagnostic Devices Regulation

Assent’s EU Medical Device Regulation Module also supports the collection, validation and centralization of compliance data for the EU In-Vitro Diagnostic Devices Regulation (IVDR). Using an interactive dashboard, companies can track additional requirements and deadlines when reporting on products intended to be used in vitro for the examination of specimens derived from the human body. By supporting rapid supplier engagement and streamlined data submissions using the secure Supplier Portal interface, companies have easy access to supplier data, and can leverage detailed reporting to proactively plan future activities.

The EU Medical Device
Regulation Substances

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.

Managing New SCIP
Database Requirements

Learn more about data requirements under Section 10.4 of the EU Medical Device Regulation.

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EU Medical Device Regulation Module Highlights:

Configurable workflows and email campaign management.

Convenient integrations to engage and educate internal employees and suppliers.

Cross-reference substances across all active Assent declarable substance list (DSL) modules.

Data and supporting documentation centralized on an accessible and secure SaaS platform.

Reliable supply chain communications through the integrated Campaign Manager.

Supports IPC-1752A XML Class D upload for an expedited declaration process, with automatically populated declarations.

The EU Medical Device Regulation Module ensures companies meet compliance and data requirements.
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