PRRC

Person Responsible for Regulatory Compliance

Maintaining compliance to the European regulations can be confusing, difficult and time consuming, especially since the release of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). 

 

With the new regulations, it is incumbent upon companies to always have a qualified regulatory expert (i.e. PRRC) at their disposal to ensure the company is meeting EU requirements.

Need a PRRC?

For our clients that fall in to the micro or small enterprises category, CENIT Consulting can represent your organization as the named PRRC in order to meet the requirements of the MDR/IVDR.

Fill out the form below to get started.

PRRC

PRRC for EU based companies.

PRRC for US Based companies operating in the European union

In order to be eligible to serve as a PRRC, an individual must have:

  1. Sufficient expertise in the field of medical devices, as well as knowledge of the regulatory requirements in the EU.

  2. Access to all relevant information relating to the conformity of the devices, as well as the technical documentation and post-market surveillance data.

  3. The ability to carry out the tasks and responsibilities required of a PRRC, which include:

  • Ensuring that the company’s devices are designed and manufactured in accordance with the requirements of the MDR or IVDR.
  • Ensuring that the company has the appropriate quality management system in place.
  • Ensuring that the company has appropriate post-market surveillance procedures in place.
  • Coordinating with the company’s notified body (if applicable) and other regulatory authorities as necessary.

If you are a US-based medical device company operating in the European Union (EU), you may need to have a Person Responsible for Regulatory Compliance (PRRC) in order to comply with EU regulations.

 

It is important to note that the PRRC must be an employee of the company or a third-party service provider with a contract in place, and must be located within the EU.

 

 

It is important to ensure that you have a PRRC who meets the requirements outlined by the MDR and IVDR.

 

 

Failure to comply with these requirements could result in fines or other penalties, as well as harm to your company’s reputation.

For our clients that fall in to the micro or small enterprises category, CENIT Consulting can represent your organization as the named PRRC in order to meet the requirements of the MDR/IVDR.

 

CENIT Consulting as your PRRC? Start the process today!

Just fill out the form to start the process. We will be in contact shortly to get all the necessary details. Our fees are flexible and will fit your needs.

Need to recruit a PRRC?

If you do not fall under the definition of a small or micro enterprise you might have to hire. CENIT Consulting has the network and knowledge in finding the right PRRC. Need help?
Recruitment

According to Article 15(3) the person responsible for regulatory compliance shall at least be responsible for ensuring that:

  1. the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
  2. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
  3. the post-market surveillance obligations are complied with in accordance with Article 10(10);
  4. the reporting obligations referred to in Articles 87 to 91 are fulfilled;
  5. in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.