One of the most frequently asked questions related to the Person Responsible for Regulatory Requirements is if that role must be established and implemented at date of application of the EU MDR and EU IVDR for those organizations which make use of the ‘transitional provisions’? What is to be expected when a PRRC is assigned within the organization? If you assign that role already although MDR or IVDR is not used yet, is compliance with MDD or IVDD violated?
Although the date of application of the EU 2017/745 Medical Device Regulations has been postponed for a year and for the EU IVDR is still some 2 years away, it is necessary to keep attentive to the establishment and assignment of a Person Responsible for Regulatory Compliance (in short, PRRC). Just one year to go…. In this contribution I will address the role of PRRC from the EU MDR perspective, although the same principles apply to the role of PRRC under the EU IVDR.
For those Manufacturers who are about to place EU MDR compliant medical devices on the market it is imperative that the PRRC role is established and implemented and when applicable, also for their respective Authorized Representative. For Manufacturers placing class I devices there is also no escape; at the date of application May 26, 2021, all the requirements of the EU MDR, including the role of PRRC must be fulfilled.
But what about those Manufacturers who want to make use of the transitional provisions, do they have to assign and install a PRRC?
The idea behind the PRRC can be found in the ‘Recitals’ where it is stated that supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance and wen applicable, also for a PRRC within a Authorized Representative. By the way, did you know that in the German transposition of the MDD already a similar role was described for a ‘safety officer’?
Article 120 of the MDR describes the requirements for the use of the transitional provisions. One can read that when making use of these provisions the requirements of this MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives. No reference is made to the applicability of the role of PRRC described in article 15. One could argue that in this situation a PRRC is not needed. But there is a catch; with the requirement of registration of Economic Operators also comes the requirement of registration of the PRRC (art. 31 and Annex VI, Part A, 1.4). A PRRC must be assigned and officially registered. Does this also mean implicitly that the obligations of that PRRC as described in art. 15 need to be fulfilled?
Our answer is yes and no. Meaning: yes, a PRRC must be assigned in order to register that person and no, only the obligations relating to post-market surveillance, market surveillance and vigilance need to be fulfilled. We can substantiate this conclusion because the requirements for the transitional provisions include reference to [all] requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices, but there is no identification of or limitation to specific articles of the MDR.
It means that one should scan the whole EU MDR for the requirements relating to post-market surveillance, market surveillance, vigilance and implement them accordingly. And several of the PRRC responsibilities are related to these aspects. The most obvious ones are the PRRC responsibility to ensure ‘post-market surveillance activities are complied with (art. 15.3 (c)) and the reporting obligations (art. 15.3 (d)) are fulfilled. It also means that a Manufacturer must document and implement these requirements in its QMS (Art. 10.9.), again including the associated responsibilities from the PRRC.
That leaves the question, when making use of the transitional provisions, do we implement all the PRRCs responsibilities or only those related to post-market surveillance, vigilance and registration? Qserve’s advice is to go all the way and implement all the PRRC responsibilities before or on May 26, 2021.
What is typically expected as auditable arrangements and evidence of implementation for a PRRC? First, the documented assignment and evidence of fulfilling the qualification requirements. Secondly all the arrangements in the documented QMS how the applicable responsibilities have been identified and documented in the QMS and finally the evidence (records) showing that those arrangement are carried out. One can chose for a separate procedure describing the applicable responsibilities of the PRRC, another solution is to integrate the PRRC in the already existing QMS documentation on post-market surveillance and vigilance. They were to be re-written anyhow, so why not include the PRRC responsibilities?
One argument not to implement the role of PRRC too quickly is that you do not yet make use of the transitional provision, because the Date of Application of the MDR (and for that matter, also for the IVDR) has not yet been reached and there is no need to fulfill the requirements of the PRRC. This sounds like a good plan, but is it? It is beneficial to consider the road towards the start of the transitional provisions as a path rather than a moment; use the time allotted to work your way upwards to MDR compliance, starting with the implementation of the role of the PRRC. There is no reason not to, implementing the role of a PRRC does not generate nonconformities with the MDD. PRRC was not mentioned in the MDD…….
Although it seems that under the transitional provisions of the EU MDR the role of PRRC does not need to be implemented, the mandatory implementation of the requirements relating to post-market surveillance, vigilance and registration of Economic Operators implicitly require the implement at least also the corresponding responsibilities of the PRRC, including the associated adaptions in the documented quality management system.
Qserve is Your MedTech Partner for Regulatory, Quality Affairs and Clinical Trials. We are the largest consultant company in the EU that is 100% focused on Medical Devices and In-Vitro Diagnostics. We provide trainings on all aspects of Medical Device Regulations, including the role of PRRC.