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Person Responsible for Regulatory Compliance

According to Medical Device Regulation (MDR EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR EU 2017/746) mandate that European device manufacturers must appoint a regulatory expert, known as the Person Responsible for Regulatory Compliance (PRRC), to verify compliance with specific EU regulations.

EU authorities have made it clear, that manufacturers designate a specific individual as the Person Responsible for Regulatory Compliance (PRRC) to guarantee the conformity of released devices, as well as the post-market surveillance (PMS) and vigilance activities related to those devices (MDR recital 34, IVDR recital 33). Manufacturers based outside the EU require a European Authorised Representative (EAR), and it is anticipated that the EAR’s PRRC will perform a secondary check to ensure the regulatory compliance of the devices produced by foreign manufacturers. The EC Rep, on the other hand, does not have nearly as many obligations as the PRRC under Section 3, Chapter 1, Article 15 of the EU MDR and IVDR.

Manufacturers and Authorized Representatives must have at least one Person Responsible for Regulatory Compliance (PRRC) with the necessary expertise and qualifications in the field of medical devices or in vitro diagnostic devices, as applicable, within the European Union. The PRRC’s responsibilities are outlined in the Regulations and further interpreted in the MDCG Guidance 2019-7, subject to future review.

PRRC for Importers and Distributors

According to Article 15, the following parties involved in the business are required to designate a PRRC

The device is sold under their name where there is no other manufacturer identified on the label (Article 16 1a)
Change the primary pack and the intended purpose of a device which is already sold on the EU market (Article 16 1b)
Modify a device which has already been sold on the market to the extent that its compliance with the regulations may be affected (Article 16 1c)

Qualification of PRRC

The sum of required qualifications and professional experience of the PRRC is either of the following as specified in Article 15 and as clarified by the MDCG Guidance 2019-7

Medical device knowledge is required
A university degree, diploma, or other formal credentials is required, and
At least one year of experience in European regulatory affairs or quality systems management linked to medical devices is required.

OR…they must have four years of professional experience in European regulatory affairs or quality systems management linked to medical devices if they do not have a university degree, diploma, or other qualification.

Experience with European regulatory issues and QMS regulations is vital. It won’t have ten years of FDA experience but little or no European RA/QA experience.

Responsibilities of PRRC Appointed by Manufacturer

MDR and IVDR Article 15 Text	Roles and responsibilities of a manufacturer
	3(a) 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	The quality management system shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation” (Article 10(9)) [10(8)].
	3(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;	Manufacturers “[of devices other than custom-made devices] shall draw up and keep up to date technical documentation for those devices” (Article 10(4) of the MDR and IVDR) and “shall draw up an EU declaration of conformity” (Article 10(6)) [10(5)]. The requirements for the Technical Documentation are in Annex II and Annex III of the MDR and IVDR, while Annex IV of the Regulations lists the information to be included in the EU declaration of conformity.
3(c) the post-market surveillance obligations are complied with in accordance with Article 10(10) [10(9)]	Manufacturers “of devices shall implement and keep up to date the post-market surveillance system” (Article 10(10)) [10(9)]. The requirements for the post-market surveillance system are described in Article 83 [78] and Annex III.
3(d) the reporting obligations referred to in Articles 87 to 91 [82 to 86] are fulfilled	Manufacturers “shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88 [82 and 83]” (Article 10(13)) [10(12)].
3(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued [in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued]	Manufacturers shall ensure that “a signed statement by the natural or legal person responsible for the manufacture of the investigational device [for performance study] that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation [performance study] and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.” (Annex XV 4.1) [Annex XIV 4.1]

Location of Manufacturer's PRRC

The regulations are silent on the specific location of the PRRC in relation to the economic operator. However, MDCG Guidance 2019-7 offers insights into the permissible locations for the PRRC. MDCG Guidance 2019-7 emphasizes the necessity of a permanent and continuous connection between the PRRC and the manufacturing activities. Consequently, it is presumed that manufacturers outside the EU should have the PRRC also located outside the EU. Conversely, for manufacturers within the EU, the PRRC is expected to be located within the EU as well.

Legal entities can appoint multiple PRRCs, each tasked with specific responsibilities tailored to the company’s needs and structure. For instance, one PRRC may ensure the technical documentation is current, while another may verify the conformity of released devices according to the manufacturing quality management system. Additionally, separate PRRCs may be designated for geographically distinct manufacturing sites. Manufacturers must document the qualifications and distinct responsibilities of each PRRC and register them in EUDAMED as outlined in paragraph 2.4. It should be noted that every legal manufacturer under a parent company is required to have a dedicated PRRC.

When dealing with multiple manufacturing sites, manufacturers may use a risk-based approach to determine the number and placement of Persons Responsible for Regulatory Compliance (PRRCs) necessary to meet the requirements. This approach should take into account the variety and classifications of devices involved. For instance, a single PRRC may suffice for numerous similar low-risk devices, whereas higher-risk products may necessitate multiple PRRCs to manage all responsibilities effectively

In the case of virtual manufacturers—organizations that source their own branded products entirely from another company, often referred to as the ‘original equipment manufacturer’ (OEM), which has designed and produced an identical CE-marked product—they are required to fulfil the obligations of the MDR/IVDR as legal manufacturers. Additionally, they must ensure that the PRRC requirements are satisfied within their relationship with the OEM.

MDCG Guidance 2019-7 stipulates that for micro or small enterprises situated within the EU, it is presumed that the Person Responsible for Regulatory Compliance (PRRC) must also be based in the EU to be permanently and continuously available to the enterprise. The MDCG Guidance 2019-7 lacks clarity on whether micro or small enterprises outside the EU are required to have their PRRC also located outside the EU. Therefore, until further clarification is provided in subsequent editions of the guidance, it is presumed that the same principle that applies to medium and large manufacturers holds true; namely, the PRRC should be situated close to the manufacturing site.

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Frequently Asked Questions

Relation between PRRC and the manufacturer’s QMS

As outlined in paragraph 2.5.1, PRRC has to carry out the QMS responsibilities

According to Article 10(9) of the MDR and Article 10(8) of the IVDR, manufacturers are required to establish a strong quality management system. This system must ensure compliance with the regulation efficiently and proportionally to the device’s risk class and type. So PRRC duties include overseeing the execution of QMS responsibilities covering IQA and periodic reviews of technical documentation

Does PMS is the obligation of PRRC?

To meet this requirement, the PRRC must possess an in-depth knowledge of post-market surveillance requirements. The MDR Articles 83 to 86 and the IVDR Articles 78 to 81 are explicit about the documentation that a post-market surveillance system must produce. For instance, the PRRC can easily be involved in approving a Post-market Surveillance Plan, Report, or Periodic Safety Update Report. However, if there are numerous product types or a small range of products with broad intended uses, the PRRC(s) may need to employ a sampling or auditing method, or serve as an approver for the procedures.

Does PRRC Obligations include reporting incidents and Field Safety Corrective Actions (FSCA)?

Yes, its the responsibility pf PRRC

The PRRC must be thoroughly familiar with all aspects of these requirements, as outlined in Section 2 of Chapter VII of the Regulations. The PRRC should audit these procedures to ensure full compliance, including trend reporting as specified in Article 88 of the MDR and Article 83 of the IVDR, and oversee all serious incident reports.

Does PRRC has any Liability Issue?

Article 15(5) of the Regulations stipulates that “The Person Responsible for Regulatory Compliance (PRRC) shall not be subjected to any disadvantage within the manufacturer’s organization for the proper execution of their duties, irrespective of their employment status within the organization.

Article 15 does not impose personal liability on the PRRC for the organisation’s non-compliance. If there is a failure to meet Article 15 requirements, it means the organisation lacks a designated individual.

The consequences for the organisation not adhering to the regulations vary based on the nature of the non-compliance and the specific articles involved. However, the PRRC is not liable in either scenario, as their obligations to the organisation are governed by the employment contract if they are an employee, or by the service contract if they are a consultant.