Introduction
The European Union Medical Device Regulation (MDR) 2017/745 introduces the significant role of the Person Responsible for Regulatory Compliance (PRRC). This requirement is primarily directed at manufacturers to ensure continuous compliance of their devices with the regulation. For medical device distributors, the obligation to designate an MDR responsible person,explores potential internal benefits of having such expertise, and outlines the specific scenarios where a distributor effectively steps into the shoes of a manufacturer, thus triggering the PRRC requirement.
The General Position: Distributors and the PRRC
Under the EU MDR, the direct legal obligation to have a Person Responsible for Regulatory Compliance (PRRC) rests primarily with manufacturers (Article 15). This individual or individuals must possess the requisite expertise in regulatory affairs relating to medical devices. Their responsibilities are extensive, covering aspects from conformity assessment and technical documentation to post-market surveillance and vigilance.
Generally, as a distributor, you are not legally required to designate a PRRC. Your main obligations, as outlined in the previous article, focus on verifying device compliance, ensuring proper storage and transport conditions, cooperating with authorities and manufacturers, maintaining traceability, and handling complaints.
Practical Reasons for Internal Regulatory Expertise
While not a legal mandate for distributors in most cases, having internal personnel with regulatory knowledge, akin to that of a PRRC, can offer significant practical benefits:
- Enhanced Compliance Understanding: A dedicated expert can help the distribution organization better understand the intricacies of the MDR, ensuring all obligations are met effectively. This can lead to fewer errors and smoother operations.
- Improved Communication: Having an in-house expert facilitates more efficient and informed communication with manufacturers, importers, and competent authorities on regulatory matters.
- Proactive Issue Management: An internal regulatory contact can help identify potential compliance issues early on and implement proactive measures to address them, minimizing risks.
- Streamlined Processes: Regulatory knowledge can contribute to the development and implementation of more efficient internal processes related to device handling, documentation, and reporting.
- Increased Confidence: Having internal expertise can boost the confidence of both the distribution team and their partners in the organization’s commitment to regulatory compliance.
While such a role might not carry the formal title of “PRRC” (as defined for manufacturers), the function and expertise can be invaluable for a distributor’s operations.
When a Distributor Becomes a “Manufacturer” and Needs a PRRC
The EU MDR stipulates specific circumstances under which a distributor can assume the obligations of a manufacturer (Article 16). In these situations, the distributor would be subject to the requirement of having a PRRC:
- Placing Devices on the Market Under Their Own Brand: If a distributor takes a device that is already CE marked and places it on the market under their own name, registered trade name, or registered trademark, they become the legal manufacturer of that device for the purposes of the MDR. This includes relabeling or repackaging where the original condition of the device could be affected.
- Changing the Intended Purpose of a Device: If a distributor modifies a device that has already been placed on the market in a way that changes its intended purpose, they are considered the manufacturer of the device with the new intended purpose.
- Modifying a Device Affecting Compliance: If a distributor modifies a device already on the market in a way that could affect its compliance with the general safety and performance requirements of the MDR, they are considered the manufacturer of the modified device. This could include significant alterations to the device’s design or functionality.
Example: A distributor purchases CE-marked wound dressings in bulk and then repackages and sterilizes them under their own brand name for sale to hospitals. In this case, the distributor assumes the obligations of a manufacturer for these repackaged and sterilized dressings and would be required to have a PRRC.
In these scenarios where a distributor takes on manufacturing responsibilities, they must establish a PRRC within their organization. Micro and small enterprises have the option of having permanent and continuous access to a PRRC who is not employed by them. However, the responsibility remains firmly with the distributor acting as the manufacturer.
Responsibilities of the PRRC (in the Context of a Distributor-Turned-Manufacturer)
When a distributor assumes manufacturing obligations and is therefore required to have a PRRC, the responsibilities of this person mirror those of a PRRC within a traditional manufacturing organization. These responsibilities, as outlined in Article 15 of the MDR, include but are not limited to:
- Verifying the conformity of devices: Ensuring that devices are appropriately assessed for conformity before they are placed on the market.
- Ensuring the technical documentation is drawn up and kept up-to-date: Overseeing the creation and maintenance of the technical files for the devices.
- Ensuring that the declaration of conformity is drawn up and kept up-to-date: Managing the formal declaration that the devices meet the relevant requirements.
- Fulfilling the post-market surveillance obligations: Overseeing the system for monitoring the performance of devices on the market.
- Fulfilling the reporting obligations: Ensuring that incidents and field safety corrective actions are reported to the competent authorities.
The PRRC must have the necessary expertise, which is demonstrated by either a diploma, certificate, or other evidence of formal qualification in a relevant field (e.g., medicine, pharmacy, engineering) and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Conclusion
While medical device distributors are not generally mandated to have a Person Responsible for Regulatory Compliance (PRRC) under the EU MDR, understanding the role is vital. There are practical internal benefits to having regulatory expertise within the distribution organization. More importantly, distributors must be acutely aware of the specific circumstances under which their activities can lead them to assume the obligations of a manufacturer. In such cases, the designation of an MDR responsible person becomes a legal necessity, carrying with it significant responsibilities to ensure the safety and compliance of the medical devices they place on the market. By understanding these distinctions, distributors can navigate the regulatory landscape effectively and ensure they meet all their obligations under the MDR.
FAQ
Q: Are medical device distributors legally required to have a Person Responsible for Regulatory Compliance (PRRC) under the MDR?
A: Generally, no. The direct legal obligation to have a PRRC primarily applies to manufacturers. However, distributors might find it beneficial to have internal regulatory expertise for smoother operations and compliance.
Q: Under what circumstances would a distributor need to designate an MDR responsible person?
A: A distributor would need to designate a PRRC if they assume the obligations of a manufacturer under Article 16 of the MDR. This occurs when they place a device on the market under their own brand, change the intended purpose of a device, or modify a device in a way that could affect its compliance.
Q: What are the responsibilities of a PRRC for a distributor who has become a manufacturer?
A: The responsibilities are similar to those of a PRRC within a traditional manufacturing organization, including verifying device conformity, managing technical documentation and declarations of conformity, overseeing post-market surveillance, and fulfilling reporting obligations.
Q: Can a distributor use an external consultant as their PRRC if they are considered a manufacturer?
A: Micro and small enterprises that assume manufacturing obligations have the option of having permanent and continuous access to a PRRC who is not employed by them. Larger distributors acting as manufacturers would typically need an employee as their PRRC.
Q: What kind of expertise is required for a Person Responsible for Regulatory Compliance?
A: The PRRC must have the necessary expertise demonstrated by specific qualifications and professional experience in regulatory affairs or quality management systems related to medical devices.