PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
Do you need a PRRC to maintain your medical devices on the EU market?
Are you affected by new MDR and IVDR regulations and need a PRRC?
PRRC stands for “Person Responsible for Regulatory Compliance”. It is a role within a company or organization that is responsible for ensuring that the organization complies with relevant regulations, standards, and laws that apply to its products, services, or operations.
The PRRC is responsible for monitoring, implementing, and maintaining compliance with applicable regulations, as well as identifying and mitigating potential risks related to non-compliance. The PRRC is also responsible for ensuring that the organization has the necessary documentation and procedures in place to support regulatory compliance.
Who needs a PRRC?
Having a PRRC can help your organization avoid legal and financial consequences of non-compliance, such as fines, product recalls, and legal actions. In addition, having a PRRC can help ensure that your organization’s products or services are safe, reliable, and of high quality, which can improve customer satisfaction and enhance your organization’s reputation.
Furthermore, some regulations, such as the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), require that certain medical devices have a PRRC on staff (article 15 of the EU MDR). Failure to comply with these regulations can result in the loss inability to market your products in the EU.
Qualifications required of a PRRC
Article 15 of the MDR / IVDR goes into more detail but put simply you have two options:
- A university degree or course of study in law, medicine, pharmacy, engineering or another relevant scientific discipline and at least one year of professional experience in quality or regulatory for medical devices
or
- 2. Four years professional experience in quality or regulatory for medical devices
Responsibilities of a Person Responsible for Regulatory Compliance
Key responsibilities are not limited to but include:
- Checking the conformity of the devices in accordance with the quality management system (QMS) before release;
- Preparing and maintaining the technical documentation and EU Declaration of Conformity
- Meeting post market surveillance obligations;
- Vigilance reporting and analysis requirements are met, including serious incidents, field safety corrective actions and report trending; and
- For investigational devices a signed statement that the device meets the GSPRs.
Overall, a PRRC is an important requirement that not only is necessary to sell and maintain products on the European market, but can also improve the quality and safety of your products or services.
Please contact us now on 01295 724286 or email us at hello@imedconsultancy.com, so that we can discuss your situation and support you with our flexible Person Responsible for Regulatory Compliance services or any other regulatory compliance needs.