Authorized Representative & PRRC Services
Non-EU medical device manufacturers must appoint an Authorized Representative (AR) to access the European market, and under MDR and IVDR, a Person Responsible for Regulatory Compliance (PRRC) is also mandatory. This guide outlines the roles and responsibilities of both the AR and PRRC, including the steps to exchange your current Authorized Representative to MediB.
Step 1:
Understand the Role of an Authorized Representative (AR)
An Authorized Representative is required for non-EU manufacturers, acting as the point of contact for EU regulatory authorities and ensuring compliance with MDR/IVDR.
Key Responsibilities of the AR:
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Maintain access to technical documentation.
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Ensure conformity assessments are completed.
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Cooperate with EU Competent Authorities and respond to regulatory requests.
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Manage post-market surveillance and vigilance reporting.
Useful link:
Step 2:
Stages to Exchange Your Authorized Representative to MediB
If you are currently using a different Authorized Representative and wish to switch to MediB, the process involves a few critical steps to ensure compliance and a smooth transition.
1. Review Your Current Contract:
Review the terms and conditions of your current AR agreement. Pay attention to any clauses regarding termination notice periods or fees.
2. Notify Your Current Authorized Representative:
Provide formal written notice to your existing AR, respecting any notice period outlined in the contract. Make sure this communication is clear and specifies the intended end date of their services.
3. Appoint MediB as Your New AR:
Contact MediB to formalize the agreement. MediB will need to review your technical documentation and ensure compliance with MDR/IVDR before assuming responsibilities as your new AR.
4. Update Product Labels and Documentation:
Once MediB is officially appointed, you will need to update your product labels, instructions for use (IFU), and technical files to reflect MediB’s details. Ensure that MediB’s name and address are listed on all relevant materials.
5. Notify Competent Authorities:
MediB will assist you in notifying the relevant EU Competent Authorities about the change in representation. This is crucial to ensure continuity in compliance and avoid market disruptions.
6. Transfer Technical Documentation:
Coordinate with your previous AR to securely transfer all technical documentation to MediB. MediB will take responsibility for maintaining and updating this information.
7. Monitor the Transition:
During the transition, monitor the process closely to ensure that all steps are completed in compliance with EU regulations. MediB will provide support to facilitate a seamless changeover.
Step 3:
Understand the Role of the PRRC
The Person Responsible for Regulatory Compliance (PRRC) is responsible for ensuring that the manufacturer adheres to MDR/IVDR regulations, especially regarding product safety and performance.
Key Responsibilities of the PRRC:
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Oversee the conformity of devices before release.
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Ensure the maintenance of technical documentation.
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Manage post-market surveillance and incident reporting.
Useful link:
Step 4:
Appoint an Authorized Representative and PRRC
Both an AR and PRRC must be appointed before launching your product in the EU market. MediB offers services as both your Authorized Representative and PRRC, ensuring compliance with all regulatory obligations.
Step 5:
Ensure Ongoing Compliance
After switching to MediB, it’s essential to ensure that your compliance processes, technical documentation, and post-market surveillance plans are up to date. The PRRC will continuously monitor regulatory changes and product performance to maintain compliance.
MediB’s AR and PRRC Services
MediB provides comprehensive Authorized Representative and PRRC services, ensuring your compliance with MDR/IVDR requirements and a smooth transition process for companies switching from another representative. Our services include:
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Managing and updating your technical documentation.
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Handling communications with EU regulatory bodies.
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Ensuring your product remains compliant with post-market surveillance and vigilance requirements.