Person Responsible for Regulatory Compliance (PRRC)

A vital role of a PRRC in your organization

A PRRC stands for Person Responsible for Regulatory Compliance. This role is crucial within organizations, particularly in industries such as the medical sector, where compliance with regulations is essential. The PRRC is responsible for ensuring that the organization adheres to relevant laws and regulations governing its operations. This includes tasks such as staying updated on regulatory changes, monitoring technical documentation, overseeing post-market surveillance, and reporting incidents. The PRRC plays a key role in maintaining compliance and ensuring that the organization operates within the bounds of the law.

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Summary

A quick overview of this page

What is PRRC?

Having a PRRC is a mandatory requirement according to Article 15 of the (EU)MDR 2017/745. A PRRC stands for Person Responsible for Regulatory Compliance. This role is crucial within organizations, particularly in industries such as the medical sector, where compliance with regulations is essential.

The responsibilities of a PRRC

Article 15 of the Medical Device Regulation (MDR) outlines the responsibilities of the Person Responsible for Regulatory Compliance (PRRC). According to this article, the PRRC is responsible for ensuring compliance with the MDR and other relevant regulatory requirements

Outsourcing the role of the PRRC

Outsourcing the role of the PRRC to an Expert consultant of Certification Experts can provide organizations with access to specialized expertise, cost savings, flexibility, and risk mitigation, ultimately contributing to improved compliance and operational efficiency.

Who We Serve

PRRC

Person Responsible for Regulatory Compliance

What is PRRC?

Having a PRRC is a mandatory requirement according to Article 15 of the (EU)MDR 2017/745. A PRRC stands for Person Responsible for Regulatory Compliance. This role is crucial within organizations, particularly in industries such as the medical sector, where compliance with regulations is essential. The PRRC is responsible for ensuring that the organization adheres to relevant laws and regulations governing its operations. This includes tasks such as staying updated on regulatory changes, monitoring technical documentation, overseeing post-market surveillance, and reporting incidents. The PRRC plays a key role in maintaining compliance and ensuring that the organization operates within the bounds of the law.

The biggest challenges for a PRRC

Outsourcing the role of the PRRC

Outsourcing the role of the PRRC to our specialized consultants can offer several benefits:

consultant

Full-service product compliance

Leave it to us.

PRRC & MDR

The connection between the PRRC (Person Responsible for Regulatory Compliance) and the MDR (Medical Device Regulation) is pivotal in ensuring adherence to regulatory standards within the medical device industry. The PRRC serves as the central figure responsible for overseeing compliance with the MDR requirements layed down in (EU)MDr 2017/745 Article 15. As mandated by the MDR, medical device manufacturers must appoint a PRRC who possesses the requisite expertise and authority to ensure conformity with regulatory obligations. The PRRC plays a crucial role in facilitating communication between the manufacturer and regulatory authorities, ensuring that all necessary procedures and documentation are in place to meet MDR standards.

Moreover, the PRRC is responsible for keeping abreast of evolving regulatory requirements and industry best practices, thereby guiding the organization in maintaining compliance with the MDR. Through their expertise and vigilance, the PRRC helps mitigate risks associated with non-compliance and contributes to the overall safety and effectiveness of medical devices in the market.

In essence, the PRRC acts as the linchpin connecting the organization’s regulatory compliance efforts with the stringent requirements outlined in the MDR, fostering a culture of accountability and diligence in ensuring the safety and efficacy of medical devices.

PRRC Responsibilities

Article 15 of the Medical Device Regulation (MDR) outlines the responsibilities of the Person Responsible for Regulatory Compliance (PRRC). According to this article, the PRRC is responsible for ensuring compliance with the MDR and other relevant regulatory requirements. Specifically, their responsibilities include:

  • Ensuring that the conformity of devices is appropriately assessed in accordance with the requirements of the MDR before they are placed on the market or put into service.
  • Overseeing the ongoing conformity of devices throughout their lifecycle, including post-market surveillance activities.
  • Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
  • Ensuring the reporting obligations in case of (reportable) incidents are fulfilled
  • Keeping up-to-date with changes in the regulatory landscape and ensuring that the organization is aware of and compliant with any new requirements.

Overall, the PRRC plays a crucial role in ensuring that medical device manufacturers comply with the regulatory requirements outlined in the MDR, thereby contributing to the safety and effectiveness of medical devices placed on the market within the European Union.

PRRC requirements

Manufacturers must appoint someone in their organization to oversee regulatory compliance for medical devices. This person needs to have the following education or expertise:

  • a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
  • four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
    Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional
    experience within a relevant field of manufacturing.

Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

but also:

Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:

  • a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
  • four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Services

Certification Experts offers the following services

QMS

Process of obtaining a QMS

1 – Gap analysis

The performance of your business unit is assessed to determine whether business requirements or objectives are being met and, if not, what steps should be taken to meet them. The output is the time spent, costs, ETC.

2 – Management system

Set up and implement a practically manageable, digital management system in accordance with the standard and your needs.

3 – Internal audit

Testing of the management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit.

4 – Management review

Assessment of the effectiveness of the management system by management or management.

5 – Guidance and certification

Guidance during the external audit by the certification body. Your company is now certified.

6 – Maintenance

Periodically update and update the management system, so that your organisation continues to meet the requirements of the standard.

Testimonials

What our clients are saying about us

Gallery Play Media

Ruben Kieftenbelt CTO
Our experience with Certification Experts was pleasant and valuable. The test results during the certification project were comprehensive and detailed and they swiftly offered solutions when there were obstacles.

Nikon

Joachim Hofmann GM Service & Support
Collaboration with the Certification team has been very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required. We look forward to collaborating for our future endeavors!

Physee

Wai-Man Tang Quality Assurance Manager
We have a wonderful experience working with Certification Experts. We are a scale-up company that specialises in doing product developments under a very tight timeline, and the team expertly adjusts to our needs and guides us step by step!

Dot Robot

Edward Belderbos Technical Director
It was a pleasure to work with Certification Experts. After reviewing our documentation, they gave us structured feedback and showed us how to proceed in order to be in compliance with European directives.

Noffz

Markus Solbach Director Sales & Marketing
Certification Experts offers great service with high flexibility and a fast response time. Their technical understanding and detailed feedback to our complex test solution in a short timeframe is impressive!

Government of Canada

Melanie Ter Meulen Trade Comissioner
Certification Experts is a valuable partner to us. The collaboration runs smooth and if Dutch companies require specific technical information, Certification Experts is able to provide this.

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Fette Compacting Belgium BV

Kris Schoeters Technical Sales Support & Project Management
The team at Certification Experts ensured a new way forward for the Fette Compacting team, wherein they ensured a higher level of safety for our operators.

Nutek

Marc Schaerlaeckens Managing Director
Certification Experts made sure to consider every possible phase of CE marking processes, ranging from how to make the right design choices to composing a technical file.

Oceanteam

Lars van ‘t Kruijs Managing Director
The team at Certification Experts provide excellent cooperation! They provide detailed explanations and think-along solutions.

Confocal.nl

Peter Drent CEO
Personally, I am very satisfied with the service and quality of the work of Certification Experts. I certainly intend to work with them for future projects!

Adtrackmedia

Paul East CTO
Certification Experts has been helpful, knowledgeable and prompt – even during difficult circumstances surrounding the pandemic. We look forward to working with Certification Experts on future projects.

Alfa Wassermann

Kurt Spiegel Vice President of Engineering
Certification Experts has been our partner for over 10 years and the relationship is outstanding. They’ve completed CE Marking, UKCA Marking, and act as our Authorized Representative. The face-to-face meetings are really important and save us a lot of time!

Bondtech Corporation

Elsa Brown President
For more than 15 years, Bondtech has had the pleasure of being partnered with Certification Experts for CE marking for Europe and the UKCA for the UK. Their professionalism, rapid responses, and attention to detail impressed us. Their tailored guidance and meticulous review of our specifications ensured compliance with CE directives. In addition to conducting the conformity assessment process for us, they also act as our Authorised Representative. We recommend Certification Experts for their expertise and personalized service, which not only secured our certifications but also provided invaluable support.

New Compliance

Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Safexpert Review 1

For us Safexpert is the ideal tool for risk assessments and CE-documentations. The structuring of plant-projects gives us the possibility also to handle big/complex projects in a clear and structured way. But also for Risk assessments for machinery outside Europe Safexpert is a very helpful tool.

Safexpert Review 2

A good software for safety analysis and risk assessment.

Safexpert Review 3

A straight one, easy to use program with many options.

Safexpert Review 4

A versatile program for the entire CE process.

Safexpert Review 5

Useful software to get CE marking. It saves a lot of time.

Safexpert Review 6

A program which helps you to get into the labyrinth of CE norms.

Safexpert Review 7

Seems to be a very strong and structured product to do Risk Assessment and CE marking.

Safexpert Review 8

A powerful and helpful program.

Full-service product compliance

Leave it to us.