Send us an email:
info@mdrc-services.com

Or use the contact form below

 

How to structure a PRRC contract for effective compliance

If you’re involved in the world of medical devices, you know that having a Person Responsible for Regulatory Compliance (PRRC) is essential for meeting EU regulations. The Medical Device Regulation (MDR) and In Vitro Diganostic Regulation (IVDR) both have specific requirements for this role laid out in Article 15 of both regulations, and a contract with your PRRC is important for staying compliant. But while it’s essential to meet these regulatory requirements, the contract with the PRRC can also be customized to fit your company’s unique needs. Here’s how to balance compliance with flexibility.

Following Article 15 MDR or IVDR

The requirements for a PRRC are nearly identical in both the MDR and IVDR, outlined in Article 15 of each regulation. For simplicity, we'll refer to these requirements collectively as Article 15, covering the responsibilities and qualifications necessary for compliance in both medical device and in vitro diagnostic sectors.

Article 15 requires that each medical device manufacturer has a PRRC on board. This person must have the necessary expertise in the medical device field.

When drafting a contract for a PRRC, it’s important to clearly outline their qualifications. These qualifications should, at a minimum, meet the baseline requirements specified in Article 15.

That said, the qualifications for a PRRC can indeed go beyond the minimum requirements outlined in Article 15. When drafting the contract, it’s wise to specify qualifications that best suit your company's specific needs and regulatory strategy.

For example, consider whether you need them to perform just the essential PRRC functions or if you could benefit from a broader range of compliance consulting services. Many PRRCs bring extensive experience in regulatory affairs and quality management, which can provide valuable insights beyond basic compliance duties.

The PRRC’s key responsibilities

The MDR and IVDR spell out specific responsibilities for the PRRC, which should be clearly detailed in the contract:

  • Ensuring that devices align with quality management system standards before being released.
  • Ensuring that technical documentation and the EU declaration of conformity are up to date.
  • Making sure that ongoing monitoring and follow-up are handled according to MDR requirements.
  • Verifying that the vigilance reporting meets requirements as outlined in MDR or IVDR.
  • When necessary, providing documentation for devices in the investigation stage.

Additionally, you can outline any extra responsibilities for the PRRC in your contract, based on your mutual agreement. This flexibility allows you to tailor the PRRC role to fit your company’s specific needs, whether that means expanding their duties beyond the regulatory minimums or incorporating additional compliance-related tasks. Which takes us to the next section of this article.

Adding flexibility with customized terms

While meeting Article 15 is non-negotiable, there’s room to tailor the PRRC contract to suit your company’s specific needs. Here are some ways to personalize it:

  • Availability - define the specific times or situations when the PRRC must be available.
  • Reporting channels - outline the reporting structure, including who the PRRC reports to within the organization.
  • Audit involvement - include responsibilities for internal audits or compliance checks.
  • Extra focus areas - add any specific areas where you’d like the PRRC to concentrate, like product development or clinical trials.

These additional terms let you adapt the PRRC role to your company’s workflow and structure, making it easier to align with your operational needs. Just make sure they complement the core duties required by the regulations and don’t create any conflicts.

The PRRC can also play a role in various other critical areas, including post-market surveillance, clinical (performance) evaluation, post-market clinical (performance) follow-up, risk management, and essentially any documentation or compliance-related activities where additional support is beneficial.

Why a solid PRRC contract matters

A well-designed PRRC contract isn’t just about meeting MDR or IVDR requirements. It provides a framework that helps both you and your PRRC understand their role clearly, balancing compliance with the day-to-day realities of your business. By combining the essentials from Article 15 with flexible terms, you can ensure that your PRRC is fully equipped to keep your company compliant, without adding unnecessary complexity. This approach ultimately supports your business and your products in the highly regulated EU medical device market.

We will help you obtain all the necessary certificates.

Learn more >>

What you need to have to succeed in certification and sell your products in the EU:

PRRC

Learn more >>

Clinical
evaluation
Learn more >>

Post-marketing
surveillance
Learn more >>

What you need to know to succeed in certification and sell your products in the EU:

CE-marking process under MDR

Learn more >>

CE-marking process under IVDR

Learn more >>

MDR checklist
Learn more >>

How to structure a PRRC contract for effective compliance

If you’re involved in the world of medical devices, you know that having a Person Responsible for Regulatory Compliance (PRRC) is essential for meeting EU regulations. The Medical Device Regulation (MDR) and In Vitro Diganostic Regulation (IVDR) both have specific requirements for this role laid out in Article 15 of both regulations, and a contract with your PRRC is important for staying compliant. But while it’s essential to meet these regulatory requirements, the contract with the PRRC can also be customized to fit your company’s unique needs. Here’s how to balance compliance with flexibility.

Following Article 15 MDR or IVDR

The requirements for a PRRC are nearly identical in both the MDR and IVDR, outlined in Article 15 of each regulation. For simplicity, we'll refer to these requirements collectively as Article 15, covering the responsibilities and qualifications necessary for compliance in both medical device and in vitro diagnostic sectors.

Article 15 requires that each medical device manufacturer has a PRRC on board. This person must have the necessary expertise in the medical device field.

When drafting a contract for a PRRC, it’s important to clearly outline their qualifications. These qualifications should, at a minimum, meet the baseline requirements specified in Article 15.

That said, the qualifications for a PRRC can indeed go beyond the minimum requirements outlined in Article 15. When drafting the contract, it’s wise to specify qualifications that best suit your company's specific needs and regulatory strategy.

For example, consider whether you need them to perform just the essential PRRC functions or if you could benefit from a broader range of compliance consulting services. Many PRRCs bring extensive experience in regulatory affairs and quality management, which can provide valuable insights beyond basic compliance duties.

The PRRC’s key responsibilities

The MDR and IVDR spell out specific responsibilities for the PRRC, which should be clearly detailed in the contract:

  • Ensuring that devices align with quality management system standards before being released.
  • Ensuring that technical documentation and the EU declaration of conformity are up to date.
  • Making sure that ongoing monitoring and follow-up are handled according to MDR requirements.
  • Verifying that the vigilance reporting meets requirements as outlined in MDR or IVDR.
  • When necessary, providing documentation for devices in the investigation stage.

Additionally, you can outline any extra responsibilities for the PRRC in your contract, based on your mutual agreement. This flexibility allows you to tailor the PRRC role to fit your company’s specific needs, whether that means expanding their duties beyond the regulatory minimums or incorporating additional compliance-related tasks. Which takes us to the next section of this article.

Adding flexibility with customized terms

While meeting Article 15 is non-negotiable, there’s room to tailor the PRRC contract to suit your company’s specific needs. Here are some ways to personalize it:

  • Availability - define the specific times or situations when the PRRC must be available.
  • Reporting channels - outline the reporting structure, including who the PRRC reports to within the organization.
  • Audit involvement - include responsibilities for internal audits or compliance checks.
  • Extra focus areas - add any specific areas where you’d like the PRRC to concentrate, like product development or clinical trials.

These additional terms let you adapt the PRRC role to your company’s workflow and structure, making it easier to align with your operational needs. Just make sure they complement the core duties required by the regulations and don’t create any conflicts.

The PRRC can also play a role in various other critical areas, including post-market surveillance, clinical (performance) evaluation, post-market clinical (performance) follow-up, risk management, and essentially any documentation or compliance-related activities where additional support is beneficial.

Why a solid PRRC contract matters

A well-designed PRRC contract isn’t just about meeting MDR or IVDR requirements. It provides a framework that helps both you and your PRRC understand their role clearly, balancing compliance with the day-to-day realities of your business. By combining the essentials from Article 15 with flexible terms, you can ensure that your PRRC is fully equipped to keep your company compliant, without adding unnecessary complexity. This approach ultimately supports your business and your products in the highly regulated EU medical device market.

Further reading

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it

EUDAMED registration - a brief guide

Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)

GSPR – General Safety and Performance Requirements for medical devices in the European Union

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

IEC 62304 - the pivotal standard for software medical devices

Medical Device Regulation (MDR) - basics

ISO and IEC standards for medical device software

Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle

Notified Bodies and their role in certification of medical devices

What is NANDO and why medical device companies should know about it?

Labeling and UDI requirements for medical devices in the EU

Understanding the roles of Authorised Representatives and Importers under MDR/IVDR

MDR implementation - challenges and solutions

Post-market surveillance under MDR and IVDR - requirements and best practices

Notified Body audit - a manufacturer's guide

Risk management plan - guide for medical device companies

Should my medical device comply with GDPR?

EC-certificate for a medical device - Q&A

How long does it take to CE-mark a medical device?

What is a PRRC?

Essential requirements for importers and distributors under MDR and IVDR

Language requirements for IFUs and labels under the MDR and IVDR

Legal Manufacturer and Original Equipment Manufacturer in medical devices

How to structure a PRRC contract for effective compliance

How to Create a Declaration of Conformity According to MDR or IVDR

All articles >>

Get in touch

We're ready to help you. Contact us whether you have a question about our solutions or need help with regulatory issues

Our EU office

MedDev Compliance Ltd
Souliou 1, Strovolos, 2018 Nicosia, Cyprus
Phone: +357 22253765
Email: info@mdrc-services.com
 

©2024 MDRC - Medical Devices Regulatory Compliance

Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

Read more >>


Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.

Send us an email:
info@mdrc-services.com

Or use the contact form below

 

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

PRRC under MDR or IVDR

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.