The document discusses the role and responsibilities of the PRRC (Person Responsible for Regulatory Compliance) within a medical device manufacturer's organization. It outlines the qualifications required to be a PRRC, their responsibilities which include ensuring device conformity and compliance with post-market surveillance obligations. It also compares the PRRC role to that of the Qualified Person in pharmaceuticals and discusses considerations around the PRRC's liabilities which are determined by national law.

1. THE PRRC
ROLE AND
RESPONSIBILITIES
Q1 Frankfurt
4 December 2019
Erik Vollebregt
www.axonadvocaten.nl

2. Agenda
• Candidate for the position
• PRRC’s role within the organization & quality team
• Incumbent responsibilities & extent of liability considerations
• Comparison with Qualified Person role in pharma

3. By the power of Grayskull:
high expections of the PRRC

4. Thinking underlying the PRRC
Recital 34 MDR and 33 IVDR:
“It should be ensured 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 who fulfils minimum conditions of
qualification.”
• PRRC is not the ISO 13845 management representative although same
person can fulfil both roles

5. Who can be PRRC?
• Qualification either through education or experience
• University degree or study recognized equivalent by a member
state; or
• Law, medicine, pharmacy, engineering or other relevant discipline
• Plus >1 year RA or QMS experience in medical devices (for MDR)
or IVDs (for IVDR)
OR
• 4 years RA/QMS experience in medical devices (for MDR) or
IVDs (for IVDR)

6. Who can be PRRC?
• Note: MDR requires MD experience, IVDR requires IVD experience
• Maintain objective evidence of qualification
• Depending on interpretation recognition of non-Union university study
necessary: “any qualification acquired outside the EU, including any
university diplomas or certificates, should have been recognised by an
EU Member State as equivalent to the EU corresponding qualification.”
MDCG 2019-7, p. 1

7. Multi persons as/for PRRC
• Multiple persons can be PRRC for the same manufacturer but will be
jointly responsible
• QMS must have procedure to define areas of responsibility
• PRRC may delegate: it should not be interpreted or expected that the
PRRC is reviewing or approving each document him or herself - can be
delegated through procedure

8. Role with/in organisation
• Have available for the manufacturer – means employed (MDCG 2019-7,
p.2)
• One for each manufacturer, also in a group of companies (MDCG
2019-7, p.2)
• Permanently and continuously at disposal for SME and AR – means
consultancy agreement
• With provisions so as to ensure the permanent and continuous
availability of that party (MDCG 2019-7, p.2)
• Do policies and procedures address the relevant requirements
concerning continuity of coverage of the activities of the PRRC (during
holidays, sick leaves etc. of the primary contact?

9. Role with/in organisation
• Location of PRRC
• “important that a close linkage, of a permanent and continuous
nature, is established between the PRRC and the manufacturing
activities” MDCG 2019-7. p. 2:
• Manufacturer outside EU – PRRC outside EU
• Manufacturer inside EU – PRRC inside EU
• Except if manufacturer is SME, then “it must be assumed
that any person to be permanently and continuously at
their disposal should be also located in the EU” (MDCG
2019-7, p. 2)
• What if manufacturer in Union but not EU (Switzerland,
Liechtenstein, Iceland, Norway, Turkey)?

10. Role with/in organisation
• Suffer no disadvantage
• Does the structure in place guarantee that the PRRC’s position is
protected from disadvantages, such as discriminatory measures
being imposed or threatened as a result of performing his/her
tasks? Examples:
• Absence or delay of promotion
• Impediments to career progression
• Denial of benefits available to other employees

11. Role with/in organisation
• Intention of PRRC is to “supervise and control”
• Do policies and procedures (or external agreement in the case of
the PRRC) provide the PRRC with access to management of the
organisation in relation to its obligations under the MDR?
• Does the PRRC participate in management review meetings?
• Implementation can be modelled after implementation of Data Protection
Officer for GDPR
• Subject to similar requirements of independence, management
access and control (but more explicitly stated in GDPR)

12. Role with/in organisation
• Management responsibilities regarding PRRC
• As management commitment QMS must include adequate
provisions to review the allocation of resources to key processes
as well as management reviews which are aimed at identifying if a
process is under-resourced
• Outsourced PRRC is (most likely) critical subcontractor
• adequate controls to demonstrate that PRRC is under control,
including selection and/or qualification criteria, as well as
process for monitoring performance/output. For critical or
high-risk suppliers, a regular audit program is also advisable.

13. Responsibilities
• “at least” – so may be more (15 (3) MDR and IVDR)
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;
b) the technical documentation and the EU declaration of conformity are
drawn up and kept up-to-date;
c) the post-market surveillance obligations are complied with in
accordance with Article 10(10) MDR / 10 (9) IVDR;
d) the reporting obligations referred to in Articles 87 to 91 MDR / 82 to 86
IVDR are fulfilled;
e) in the case of investigational devices, the statement referred to in
Section 4.1 of Chapter II of Annex XV MDR / XIV IVDR is issued
• Cross-references of these responsibilities to manufacturer
responsibilities in article 10 MDR and IVDR in MDCG 2019-7, p. 3-4

14. Responsibilities
• manufacturer should be ready to demonstrate through records that the
person responsible for regulatory compliance has been acting in the
expected capacity
• PRRC must have auditable systems for being able to demonstrate
this

15. PRRC of AR
• Manufacturer PRRC and AR PRRC cannot be the same (MDCG 2019-7,
p.3)
• Must be located in EU (MDCG 2019-7, p.5)
• Responsible for ensuring that the tasks of an AR as specified in the
given mandate, in accordance with Article 11(3) (MDCG 2019-7, p. 5)
• 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 (MDCG 2019-7, p. 5)

16. Liabilities
• Article 15 (3): “the PRRC shall at least be responsible for ensuring that”
• What does that mean? (remember: “supervise and control”)
• Liabillity not defined in MDR or IVDR, so matter of national law –
good idea to include PRRC under directors and officers insurance:
• Tort, employment law, MDR/IVDR implementation
(administrative or penal sanctions)
• Sometimes implementation of MDR/IVDR is not so clear (NL
for example: infringement of 15 (3) MDR/IVDR (by whom?) is
subject to enforcement and penalty).
• AR PRRC
• May have a role in product liability of the AR – depends on
national law

17. Liabilities
Liabilities are a matter of national law if not clearly set out in MDR / IVDR
(see TUV Rheinland case at ECJ)
• Member states do not always implement very practically, see for
example Netherlands implementation:
• ‘Our Minister may impose a penalty payment for enforcement of
[…] article 15 (1) – (4) MDR and IVDR (article 12 (a) and (b)
implementation act)
• ‘Our Minister may impose an administrative fine of max €€€ for
any conduct contrary to […] Article 15 MDR and IVDR’ (article 14
(2) (a) and (b) implementation act)
• Impose on whom – manufacturer, PRRC or both/optional? Does
not say in law, does not say in Explanatory Memorandum to Dutch
implementation act – while article 15 (3) seems to impose direct
responsibility on PRRC

18. PRRC = QP / QPPV?
• Similar but different so careful with arguments by analogy
• “permanently and continuously at his disposal the services of at
least one qualified person” – employment not needed, 24/7 single
contact point
• Both must have means to carry out duties
• QP change must be notified to authorities, PRRC goes into
Eudamed in relation to the manufacturer and AR
• Article 49 (2) MPD is clear about university study not needing MS
recognition (“university course of study, or a course recognized as
equivalent by the Member State concerned” (comma makes all
the difference)), and has more elaborate educational options
• Two years of practical experience (instead of one for MD/IVD)
• Obligation to check imported medicines (article 51 (1) (b) MPD)
• Obligation to verify GMP for imported products and to keep batch
release register for at least five years (article 51 (2) and (3) MPD)

19. PRRC = QP?
• Sanctions can explicitly be directed against QP (article 52 MDP), while
this is unclear for the PRRC
• Member States shall ensure that the duties of QPs are fulfilled,
either by means of appropriate administrative measures or by
making such persons subject to a professional code of conduct.
• Member States may provide for the temporary suspension of
such a person upon the commencement of administrative or
disciplinary procedures against him for failure to fulfil his
obligations.

20. PRRC = QPPV?
QPPV (article 104 (3) MPD) – overlap with PRRC for PMS and vigilance
• shall reside and operate in the Union (not PRRC)
• shall be responsible for the establishment and maintenance of the
pharmacovigilance system (PRRC for article 10 (10) MDR PMS system
and vigilance reporting obligations) .
• The marketing authorisation holder shall submit the name and contact
details of the qualified person to the competent authority and the Agency
(PRRC details go in Eudamed (Annex VI, part A)
• Must be available during pharmacovigilance inspections (not for PRRC)
• Lots of other interesting and practical guidance re QPPV in Guideline on
good pharmacovigilance practices (GVP) Module I – Pharmacovigilance
systems and their quality systems, section I.C

21. MDCG guidance to be revised
• Not a very well drafted document
• Slated to be revised next year

22. Thanks for your attention!
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
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