Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance
Person Responsible for Regulatory Compliance
Person Responsible for Regulatory Compliance (PRRC)
In accordance with Article 15 of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), micro and small enterprises are not required to have a PRRC within their own organisation, provided that they have permanent and continuous access to such expertise.
According to Commission Recommendation 2003/361/EC, micro and small enterprises are defined as follows:
- Micro enterprise: Fewer than 10 employees, and an annual turnover or annual balance sheet total not exceeding EUR 2 million;
- Small enterprise: Fewer than 50 employees, and an annual turnover or annual balance sheet total not exceeding EUR 10 million.
Responsibilities of the PRRC
The PRRC is responsible for ensuring that:
- The conformity of devices is appropriately checked in accordance with the manufacturer’s quality management system, prior to release;
- The technical documentation and the EU Declaration of Conformity are properly drawn up and kept up to date;
- Post-market surveillance (PMS) obligations are fulfilled;
- Vigilance and reporting requirements are met in accordance with the applicable regulations;
- For devices under investigation, the declaration referred to in Annex XV, Section 4.1 (MDR) or Annex XIV (IVDR) is issued, as applicable.
Multiple PRRCs may be appointed where justified by the organisation’s structure and activities. Responsibilities may be allocated among several PRRCs to ensure that all regulatory obligations are adequately covered.
EUDAMED and Regulatory Registration
Manufacturers and Authorised Representatives are required to provide the name, address, and contact details of the PRRC(s) at the time of registration in EUDAMED and, where applicable, when placing devices on the market.
Our PRRC Service
MDQ Services Ltd provides PRRC services to support manufacturers and Authorised Representatives in meeting their regulatory obligations, ensuring continuous access to qualified regulatory expertise in compliance with MDR and IVDR requirements.
MDQ Services Ltd provides PRRC (Person
Responsible for Regulatory Compliance) services
that are designed to be:
Tailored
Tailored
The PRRC service is provided under an annual service fee, reflecting the regulatory responsibilities associated with the appointment of a Person Responsible for Regulatory Compliance.
Fees are structured according to company size, device portfolio, and regulatory complexity.
All activities are clearly defined and detailed in a transparent and accurate service agreement.
Performance driven
Performance driven
We support regulatory compliance oversight activities, including post-market surveillance coordination, vigilance management, and regulatory reporting in accordance with MDR and IVDR requirements.
Our team understands the importance of data-driven regulatory control and knows how to access, evaluate, and interpret quality, clinical, and regulatory information to ensure continuous compliance.
Fully Compliant
Fully Compliant
One of our qualified regulatory professionals is designated as PRRC and oversees the regulatory conformity of your medical devices.
Compliance is systematically monitored and verified in line with Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), and applicable competent authority expectations, ensuring robust and reliable regulatory oversight.
Looking for a PRRC (Person Responsible for Regulatory Compliance) for your medical devices?
We’re here to help!
Looking for a PRRC (Person Responsible for Regulatory Compliance) for your medical devices?
We’re here to help!
e take the time to fully understand your specific needs, enabling us to deliver the most appropriate solution.
Let us know what you are looking for, and our team will be pleased to support you.