Medical device manufacturers are responsible for the safety and performance of their products- but for those outside the European Union, an Authorised Representative (AR) becomes a critical partner for success.

Acting as the bridge between manufacturers and regulators, authorised representatives play a significant role in post-market surveillance, vigilance activities, and the implementation of Corrective and Preventative Actions (CAPA).

This article explores how authorised representatives help manufacturers stay compliant under the Medical Device Regulation (EU) 2017/745 (“MDR”) and the In Vitro Diagnostic Regulation (EU) 2017/746 (“IVDR”).  

Understanding the Roles:

Before diving into the specifics, it’s essential to understand the core responsibilities:

• Manufacturer: Holds the primary responsibility for device safety and performance, including post-market surveillance and CAPA implementation.
• Authorised Representative (AR): Acts as the manufacturer’s representative within the European Union, responsible for communication with regulators, storing documentation, and fulfilling certain regulatory obligations.  
• Vigilance: The systematic process of monitoring medical devices post-market to identify and investigate adverse events and trends.
• CAPA: A systematic process to identify, address, and prevent the recurrence of nonconformities or other quality issues related to medical devices.  

Even though the non-EU manufacturer has ultimate responsibility for the post-market surveillance system, their authorised representative is a key partner in supporting their activities.

How do Authorised Representatives Strengthen Vigilance?

ARs provide invaluable support to manufacturers in managing vigilance cases, including:

• Reporting Adverse Events: Authorised representatives are a main contact for receiving adverse events (e.g. from patients, healthcare professionals, users). They also can support manufacturers with compiling incident reports and submitting them to the authorities. Therefore, ARs ensure faster, more complete vigilance reporting.
• Handling Regulatory Communication: Authorised representatives act as the manufacturer’s official liaison, responding to authority inquiries, providing additional documentation, and representing the company in meetings or investigations. Their local presence and understanding of the regulatory landscape are invaluable in these interactions.  
• Trend Analysis: ARs can assist manufacturers in identifying trends in non-serious incidents. By assisting in the compilation and analysis of vigilance data, authorised representatives help manufacturers proactively identify potential safety risks and implement appropriate measures, in accordance with Article 88 MDR/ Article 83 IVDR.
• Supporting Periodic Summary Reporting: For certain serious incidents, authorised representatives can help prepare periodic summary reports, ensuring proportionate and compliant management of known and characterised serious incidents.
• Maintaining Vigilance Records: Authorised representatives maintain vigilance records, promoting compliance with regulatory requirements and facilitating audits.

How can Authorised Representatives support CAPA implementation?

The AR’s role extends beyond reporting and communication to supporting the manufacturer in the CAPA process:

• Navigating Regulations: Authorised representatives possess a deep understanding of the regulatory requirements related to medical device CAPAs. They guide manufacturers, ensuring the right documentation, timelines, and procedures are met.  
• Supporting Communication: Authorised representatives liaise with manufacturers, distributors, and healthcare facilities. This ensures relevant parties are informed and involved in the process.  
• Monitoring CAPA Effectiveness: Whilst the manufacturer owns the CAPA, the authorised representative can assist in monitoring the implementation and impact of corrective actions. They can gather feedback from distributors and users to assess whether the actions have been effective in addressing the root cause.
• Supporting Field Corrective Actions: In cases requiring field corrective actions, such as recalls or device modifications, the AR coordinates directly with local authorities to execute actions quickly and efficiently.

Benefits of Authorised Representative Involvement:

The involvement of an authorised representative in vigilance and CAPA processes offers multiple benefits:

• Stronger Compliance: ensure compliance with regulations, protecting patients and users while minimizing regulatory risks.  
• Enhanced Communication: facilitate clear and effective communication with regulatory authorities and other stakeholders.  
• Faster Response Times: respond quickly to adverse events and regulatory inquiries.
• Reduced Burden on Manufacturers: free manufacturers to focus more on product innovation and manufacturing.

Conclusion:

Authorised Representatives are key for non-EU manufacturers to fulfil their vigilance obligations. Their expertise in vigilance activities and their direct communication with regulators improves device safety and compliance.

By leveraging the expertise and local knowledge of authorised representatives, manufacturers can effectively manage post-market surveillance and maintain the highest standards of product safety and performance.

The support provided by authorised representatives also creates efficiencies by streamlining vigilance activities, allowing the manufacturer to focus on product optimisation and commercialisation.