USDM Life Sciences offers many solutions to help plan, execute, and manage any or all enterprise-wide activities necessary to meet the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.

Medical device manufacturers must comply with EU MDR by May 26, 2021 and IVDR by May 26, 2022.
 

Developing EU MDR and IVDR Compliance in your Organization

USDM’s EU MDR and IVDR compliance solutions include:

  • Gap assessment and product portfolio rationalization
  • Economic Operator (EO), device registration, and UDI Database submissions
  • Assess devices with valid MDD/AIMD certificates that will be distributed after 2020
  • Assess devices that will be (re)certified to the EU MDR
  • Assess Class I devices and systems and procedure packs that must be EU MDR compliant by 2020
  • Assess EO, assess AR, importer, distributor compliance (enhanced responsibilities of other economic operators including traceability)
  • Assess QMS (ISO 13485:2016 as standard), identifying additional SOPs or changes to existing SOPs required to manage EU MDR, including UDI

European Databank on Medical Devices (EUDAMED) Submission Solutions

USDM’s Organizational Readiness Assessment for EUDAMED includes: 

  • Complete assessment of supply chain and regulatory activities required to support the submission of data to EUDAMED
  • Inventory of medical devices subject to EUDAMED regulatory requirements for further assessment
  • Identify process improvements to support the submission of data to EUDAMED
  • Assess the overall readiness of the organization to meet EU regulatory reporting requirements

USDM’s System Validation for EUDAMED includes:

  • Conduct system validation activities required for EUDAMED submissions
  • Identify any system integration issues and recommend corrective actions
  • Identify process and documentation improvements necessary to meet EU regulatory requirements
  • Deliver system validation activities and documentation for new or modified systems

USDM’s UDI Data Validation for EUDAMED includes:

  • Conduct validation activities on the data required for EUDAMED submissions
  • Identify any data integrity concerns that may delay EUDAMED that may delay EUDAMED submissions
  • Assess areas for improvement to prepare for and expedite data submissions to EUDAMED

FAQ

  • Does MDR and IVDR only apply to companies based in the EU?

    The EU MDR and IVDR apply to a medical device placed on the EU market after the applicable Date of Application (DoA). Moreover, many other countries leverage a CE mark for market authorization. 
     
    The EU MDR also added a lot of products (Annex XVI) that, though they have no specific “medical” purpose (e.g., cosmetic contact lenses), are now also regulated as devices.

  • Do medical device companies in the UK need to be EU MDR/IVDR compliant?

    In preparation for Brexit, the UK has published its own version of the EU MDR/IVDR, which mirrors the EU versions. Moreover, since the UK will not be part of the EU, companies outside of the UK will also need a UK “responsible person,” much like an EU Authorized Representative (AR). For companies based in the UK, they will now need an AR and importer to place products on the EU market.

  • Do medical device companies in the UK need to be MDR/IVDR compliant?

    In preparation for Brexit, the UK has published its own version of the MDR/IVDR, which completely mirrors the EU versions. Moreover, since the UK will not be part of the EU, companies outside of the UK will also need a UK “responsible person” – much like an EU Authorized Representative (AR). For companies based in the UK, they will now need an AR and importer to place products on the EU market.

  • Does the EU MDR and IVDR supersede all other EU medical device regulation legislation in place?

    Yes, the MDR supersedes both the Medical Device Directive (MDD) and the Active Implantable Device Directive (AIMD). The IVDR supersedes the IVD Directive (IVDD).

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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