PRRC For European Authorized Representative E.A.R.

As per the Regulation's Article 15(6), authorized representatives (E.A.R.) shall have permanently and continuously at their disposal at least one PPRC with proper expertise in the field of medical devices or in vitro medical devices, as applicable, in the European Union.  
  It is one of the requirements of the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR)

Who can be a PRRC?

 The MDCG Guidance 2019-7 states that the authorised representative may subcontract the responsibilities of a PRRC to a third party, as long as the qualification
criteria is met, and the authorised representative can demonstrate and document how they can meet their legal obligations. Therefore, the PRRC may be part of an external organisation, with which the authorised representative has established a contract laying down provisions to ensure the permanent and continuous availability of that party.

 The contract should mention the relevant person’s qualifications, demonstrating compliance with points a) or b) of Article 15 (1). The MDCG Guidance 2019-7 underlines that the PRRC for an authorised representative and for an ‘outside EU’ manufacturer cannot be the same person. The guidance justifies this position as the aim is for the authorised representative “to be adding a level of scrutiny and ensure that the supervision and control of the manufacture of devices, and the relevant post-market surveillance and vigilance activities, are adequately effected. If the two roles were conducted by the same person, the additional level of scrutiny would be undermined. For the same reason, the PRRC of a micro or small enterprise and the PRRC of the authorised representative of that same enterprise shall not belong to the same external organisation”.

 Taking into account that the AR is located in the EU, the MDCG Guidance 2019-7 states that it must be assumed that the PRRC (to be permanently and continuously at disposal of the AR) should be also located in the EU.

responsibilities of a PRRC under the MDR

 The PRRC of a E.A.R is responsible for ensuring that:

  • Verification that the declaration of conformity and technical documentation have been drawn up and that, where applicable, the appropriate conformity assessment procedure has been conducted
  • Keeping available a copy of the technical documentation, the declaration of conformity and, if applicable, the relevant certificate issued by the Notified Body at the disposal of competent authorities
  • Complying with the obligations to register the following information in EUDAMED AR and AR PRRC details (Article 31 [28] and Annex VI Part A, Section1)
  • Verification that the manufacturer has registered UDI information as per Article 27and details of devices registered (Article 29 [26])
  • In response to a request from a competent authority, providing that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned
  • Forward to the manufacturer any request by a competent authority of the member state in which the E.A.R has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device
  • Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated
  • Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation

As per Article 11(3(h) and 11(6)s, the E.A.R shall terminate the mandate if the manufacturer acts contrary to its obligations under the Regulations, shall inform the competent authority of the Member State in which the E.A.R is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefore.

OUR price

500 EUR
per annum

I class MDR CLASS A IVDR

1000 EUR
per annum

II a, B class MDR Class C,B IVDR

from 2000 EUR
per annum

III class MDR Class D IVDR

Contact us

REQUEST PRRC for E.A.R
ABOUT US

Consulting Agency "AFINA"
European Regulatory Compliance Services

SOCIAL NET
Contact US
OUR AdDresS

Kaprova 42/14

Prague 110 00

+420 608 049 029

Czechia

 

AFINA s.r.o. © 2023

privacy policy cookie-policy