European Authorized Representative Under MDR/IVDR: IGJ Inspection

The medical device industry plays a pivotal role in healthcare, ensuring access to essential devices while upholding stringent regulatory standards. Recently, the Competent Authority in the Netherlands, Healthcare and Youth Inspectorate (IGJ), released findings from inspections of European Authorized Representatives (EARs), shedding light on compliance issues and the evolving industry landscape. The Dutch Competent Authority conducted inspections of EARs, spearheading a survey on the level of compliance of the EAR as an Economic Operator under the MDR and IVDR. This survey is anticipated to be circulated amongst the Competent Authorities in all other EU Member States. In this blog, we delve into the rise of EARs, the IGJ’s inspection focus, and the key findings.

Examining European Authorized Representatives

Since 2019, the Netherlands has seen a remarkable increase in the number of registered EARs, from 170 to 347 by 2022. This surge can be attributed to two main factors:

• • • • the COVID-19 pandemic, which led to a rapid demand for medical devices, particularly those related to the virus, and
      • Brexit, which necessitated the relocation of EARs from Great Britain to EU member states.

These events have not only increased the number of EARs but have also heightened the importance of regulatory oversight.

IGJ Inspection Focus Points

The IGJ’s inspections, conducted from November 2022 to September 2023, targeted 24 EARs representing three or more manufacturers outside the EU. The inspections were based on an assessment framework that focused on three key themes:

1. The mandate between the agent and the non-EU manufacturer.

2. The knowledge and experience of the Person Responsible for Regulatory Compliance (PRRC).

3. The responsibilities of the authorized representative for the manufacturers they represent.

Key IGJ Inspection Findings on European Authorized Representatives

1. Postal Address EARs: Some EARs were found to be mere postal addresses without a physical presence, with their principal offices and operations located outside the EU.

2. PRRC Performance: Although all Person Responsible for Regulatory Compliance (PRRC) appointees formally met the statutory requirements, their practical performance often fell short, raising doubts about their ability to fulfill their duties effectively.

3. Single-Employee EARs: In cases where only one person was employed, that individual also served as the PRRC, with no contingency plans in place should they become unavailable.

4. Verification Shortcomings: Authorized representatives sometimes possessed the required documentation but failed to demonstrate that they had verified its accuracy, casting uncertainty on whether the medical devices met legal standards.

IGJ Identifies Violation for European Authorized Representatives

The IGJ’s inspections of 24 EARs, which focused on mandates, PRRC knowledge and experience, and the responsibilities of authorized representatives, uncovered violations in over one-third of the cases. While some EARs rectified issues immediately, others faced warnings or fines, with the expectation of resolving all violations promptly.

Compliance Recommendations

The IGJ’s recommendations are crucial for all authorized representatives within the EU. They emphasize the need for EARs to take their legal duties seriously and for manufacturers to select EARs who will ensure product safety and quality.

Impact on European Authorized Representatives’ Compliance

The IGJ’s recent inspections of EARs mark a significant step in assessing compliance under the MDR and IVDR. This initiative, spearheaded by the Dutch Competent Authority, sets a precedent for regulatory scrutiny within the EU. The survey conducted by the Dutch Competent Authority on EAR compliance will be shared among other Competent Authorities in EU Member States, facilitating cross-border cooperation in ensuring regulatory compliance. It’s imperative for EARs and manufacturers to heed these insights, ensuring adherence to regulatory standards across borders. While these efforts may lead to industry improvements, collaborative compliance remains paramount in upholding trust and ensuring patient safety.

Click here to read the full report from the Healthcare and Youth Inspectorate (IGJ).

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If you have questions about the compliance requirements of the EAR as an Economic Operator under the MDR and IVDR, contact us so we can help you. 

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• • EU Authorized Representative (EAR)
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  • Medical Device CE Marking Compliance