Person responsible for compliance with regulations
The Person Responsible for Regulatory Compliance (PRRC) plays a key role in ensuring that medical devices comply with the applicable regulatory requirements before and after they are placed on the market. For manufacturers and authorized representatives, the PRRC helps maintain control over device conformity, technical documentation, post-market surveillance and reporting obligations.
Micro and small businesses are not required to have a PRRC within their organization, but they must have this resource available to them on an ongoing basis. This makes external PRRC support particularly important for companies that need continuous regulatory compliance expertise without creating a dedicated internal role.
ALTRION provides PRRC services for medical devices, supporting companies with product evaluation, documentation review, post-market analysis, reporting and compliance verification according to MDR requirements and competent authority expectations.
In accordance with Commission Recommendation 2003/361/EC, micro and small enterprises are defined according to company size and economic parameters. Micro enterprises generally have fewer than 10 employees, while small enterprises generally have fewer than 50 employees, together with the applicable annual turnover or balance sheet criteria.
These companies may not be required to appoint an internal PRRC, but they must still ensure that a qualified resource is available on an ongoing basis. ALTRION can provide this service, helping micro and small businesses maintain access to the regulatory expertise needed to support device compliance.
The annual amount is determined based on the size of the company and the number of product families marketed. Each activity is then defined in a detailed quotation.
Post-market analysis and reporting. The importance of performance monitoring is widely recognized.
We know where to find the information.
We handle product evaluation and documentation in the initial phase; device compliance will be adequately verified according to MDR requirements and those of the competent authorities.
The PRRC for medical devices must ensure that the conformity of the device is adequately checked before release, in accordance with the manufacturer’s quality management system.
This responsibility helps verify that the device has been reviewed against the applicable internal and regulatory requirements before being made available. ALTRION supports companies by helping evaluate product compliance and documentation in the initial phase, ensuring that conformity is assessed according to MDR requirements and the expectations of competent authorities.
A central PRRC responsibility is ensuring that the Technical Documentation and the EU Declaration of Conformity are drawn up and kept up to date.
For medical device companies, this activity is essential because documentation must reflect the current regulatory status of the device, its intended use, its technical evidence and any relevant updates. ALTRION supports documentation review and compliance verification, helping companies maintain a more controlled and reliable regulatory file.
The PRRC must ensure that Post-Market Surveillance (PMS) obligations are properly managed throughout the device life cycle. PMS allows manufacturers to collect and evaluate information after market placement, monitoring device performance, identifying potential issues and supporting continued regulatory compliance.
ALTRION assists with post-market analysis and reporting, helping companies organize the relevant information, review performance data and maintain a structured approach to PMS activities. This support helps ensure that post-market evidence remains aligned with MDR requirements and with the manufacturer’s broader regulatory responsibilities.
Reporting obligations are another key part of PRRC responsibilities. The PRRC must ensure that the required reporting activities are properly managed and aligned with applicable regulatory expectations.
ALTRION helps companies approach reporting with greater clarity, supporting the organization of post-market information and regulatory documentation. This can be particularly useful for companies that need external regulatory support to maintain consistency across PMS, documentation and compliance activities.
In the case of devices under investigation, the PRRC must ensure that the declaration referred to in Section 4.1 of Annex XV of the MDR and Annex XIV of the IVDR is issued where applicable.
This responsibility shows that the PRRC role is not limited to products already marketed. It can also be relevant in specific regulatory contexts involving investigational devices, where documentation and declarations must be handled carefully and in line with the applicable framework.
Multiple PRRCs may be appointed, and responsibilities may be delegated to other PRRCs until all activities are completed. This can be useful for organizations with different product families, complex portfolios or multiple regulatory activities requiring specialized oversight.
ALTRION can support companies in defining the scope of PRRC activities according to their needs, helping ensure that responsibilities are clear and that regulatory control remains active throughout the required process.
Manufacturers and authorized representatives must provide the name, address and contact details of the person responsible for regulatory compliance when registering in EUDAMED or when marking devices.
This requirement makes the PRRC a visible and formal part of the regulatory compliance structure. ALTRION supports companies that need this service, helping them manage the practical and documentary aspects connected to PRRC availability and regulatory identification.
ALTRION’s PRRC services can be tailored to the specific characteristics of the company. The annual amount is determined based on the size of the organization and the number of product families marketed.
Each activity is then defined in a detailed quotation, allowing companies to receive a PRRC service aligned with their real structure, product portfolio and regulatory needs. This custom-made approach is particularly useful for micro and small businesses that need ongoing support without adopting a standard, oversized solution.
What is a PRRC for medical devices?
A PRRC, or Person Responsible for Regulatory Compliance, is the person responsible for ensuring that specific regulatory compliance obligations are met for medical devices, including conformity checks, documentation, PMS and reporting.
Do micro and small businesses need an internal PRRC?
Micro and small businesses are not required to have a PRRC within their organization, but they must have this resource available on an ongoing basis. ALTRION can provide this external PRRC support.
What does the PRRC check before device release?
The PRRC must ensure that the conformity of the device is adequately checked before release, according to the manufacturer’s quality management system and applicable regulatory requirements.
Does the PRRC manage Technical Documentation?
The PRRC must ensure that Technical Documentation and the EU Declaration of Conformity are drawn up and kept up to date. ALTRION supports documentation review and regulatory compliance verification.
Can more than one PRRC be appointed?
Yes. Multiple PRRCs may be appointed, and control may be delegated to other PRRCs until all activities are completed, depending on the organization’s structure and regulatory needs.
ALTRION provides PRRC support designed around the company’s size, product families and regulatory activities. The service can include product evaluation, documentation review, post-market analysis, reporting and compliance verification in the initial phase and throughout the device life cycle.
This allows medical device companies to maintain access to a qualified regulatory compliance resource while keeping the service proportionate to their organization and product portfolio.
PRRC responsibilities require ongoing attention, especially when Technical Documentation, EU Declarations of Conformity, PMS activities and reporting obligations must remain aligned over time.
ALTRION helps companies manage these responsibilities with a practical and structured approach, supporting regulatory compliance according to MDR requirements and competent authority expectations. For micro and small businesses, this creates a reliable path to continuous PRRC availability without the need to create a dedicated internal function.
