PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

What is PRRC?

According to the European Medical Device Regulation (MDR) - “Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.” (MDR Article 15.1).

 

As such, PRRC means 'Person Responsible for Regulatory Compliance'. The same is required by the In-Vitro Diagnostic Regulation (IVDR) for such manufacturers.

 

The PRRC is responsible to ensure that the manufacturer will comply with at least, the following requirements:

  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.

Who can be PRRC?

The one aiming to assume the role of PRRC is a person who possesses a requisite expertise in the field of medical devices. The MDR defines the requisite expertise as having one of the 2 options below:

 

  1. A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of a course of study recognized 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;

  2. Four (4) years of professional experience in regulatory affairs or in quality management systems relating to medical devices.     

 

Important Note (!)

Authorized representatives shall also have permanently and continuously at their disposal at least one person responsible for regulatory compliance (Art 15). The PRRC at the side of the AR needs to have same qualifications as the PRRC at the side of the manufacturer.

 

Can a PRRC be outsourced?

Yes it can!

The Medical Device Regulations (MDR & IVDR) require Manufacturers to have available within their organization at least one person responsible for regulatory compliance(Art 15.1). However, Micro & Small Enterprises (up to 50 ppl. & up to 10 Million turnover) are not required to have the PRRC within their organization but they shall have such person permanently and continuously at their disposal.

 

If PRRC is indeed outsourced (i.e. not within the manufacturer organization) - how is “Continuously and Permanently” defined?

 

It should be defined by means of a signed agreement stipulating conditions, availability, qualifications, responsibilities, tasks & objectives – covering issues such as:

  • PRRC does not need to be physically present at all times.

  •  PRRC May delegate some tasks/responsibilities but remains responsible for meeting objectives.

  •  There is no minimum time requirement - as long as the tasks are fulfilled.

  •  It is recommended to have one or more deputy to the PRRC – to ensure “continuity and permanence”

 

PRRC must offer availability in case of unannounced audits (NB or CA).

Do you need to designate a PRRC but you don’t know how?
Have you been designated as PRRC and you need support?