PRRC for Medical Devices

Person Responsible for Regulatory Compliance (PRRC)

Under the MDR (EU) 2017/745 and IVDR (EU) 2017/746, manufacturers are required to have access to a Person Responsible for Regulatory Compliance (PRRC).

Micro and small enterprises are not required to have a PRRC within their organization, but they must have permanent and continuous access to this function.

According to Commission Recommendation 2003/361/EC:

• Micro enterprises: fewer than 10 employees and limited annual turnover or balance sheet
• Small enterprises: fewer than 50 employees and limited annual turnover or balance sheet

PRRC Responsibilities

The PRRC ensures that:

• The conformity of devices is appropriately checked in accordance with the manufacturer’s Quality Management System prior to release
• Technical documentation and the EU Declaration of Conformity are properly prepared and kept up to date
• Post-Market Surveillance (PMS) obligations are fulfilled
• Regulatory reporting obligations are met
• For investigational devices, the declaration referred to in Annex XV (MDR) and Annex XIV (IVDR) is issued

Organizational Structure

Multiple PRRCs may be appointed within an organization. Responsibilities can be distributed and coordinated among different PRRCs to ensure that all regulatory activities are properly managed.

Regulatory Requirements

Manufacturers and Authorized Representatives must provide the name, address, and contact details of the PRRC when:

• Registering in EUDAMED
• Placing devices on the market

Our Services

ALTRION provides qualified PRRC services, ensuring continuous regulatory oversight, compliance with MDR and IVDR requirements, and reliable support throughout the entire product lifecycle.

PRRC Services

ALTRION’s services as a Person Responsible for Regulatory Compliance (PRRC) are designed to be flexible, structured, and aligned with the specific needs of each manufacturer.

Custom-Made

Our PRRC services are tailored to each organization.

The annual fee is determined based on:

• The size of the company
• The number of product families marketed

Each activity is defined in detail through a structured quotation.

Performance

We support:

• Post-market analysis and reporting
• Continuous monitoring of device performance

The importance of performance monitoring is widely recognized, and our approach ensures that relevant data is properly collected, analyzed, and utilized.

Compliance

We support manufacturers from the initial stages, including:

• Product evaluation and documentation review
• Verification of device compliance in accordance with MDR requirements and Competent Authority expectations

Our goal is to ensure that all regulatory obligations are met efficiently and consistently throughout the product lifecycle.