Embracing the role of PRRC is not just a regulatory
requirement—it’s a commitment to excellence in healthcare delivery.
In the intricate world of
medical device regulations, the European Union’s Medical Device Regulation (EU
MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) stand as a
bulwark to ensure safety, efficacy, and accountability. Among the pivotal
elements of these frameworks is the role of the Person Responsible for
Regulatory Compliance (PRRC), a key figure mandated under Article 15 of both
regulations.
Without a PRRC, a
manufacturer may face delays or denials in obtaining CE markings, hindering the
ability to market products within the EU. Some EU member states have
established penalties for non-compliance with MDR/IVDR requirements. For
instance, Italy has implemented fines ranging from €20,000 to over €150,000 for
various infringements related to the MDR. Non-compliance may lead to product
withdrawals or recalls, preventing manufacturers from selling their devices in
the EU market.
Addressing the root causes
of these denials is crucial to overcome obstacles effectively. Technical and
scientific expert Kirti Salunke from I3CGlobal
highlights key provisions of Article 15 of these regulations, that mandate the
appointment of a “Person Responsible for
Regulatory Compliance” (PRRC). The PRRC is not only a compliance figurehead
but also a strategic partner in ensuring product integrity and facilitating
market access.
Compliance
Requirements for PRRC
1.
For Large Manufacturers, as outlined in Article 15(1) and
elaborated by MDCG Guidance 2019-7, large manufacturers—employing over 50
people with an annual turnover exceeding €10 million—must appoint an in-house
PRRC. For conglomerates with multiple legal manufacturers, each must individually
designate a PRRC to maintain regulatory compliance.
2.
Micro and Small Manufacturers that
employ fewer than 50 persons and whose annual turnover and/or annual balance
sheet total does not exceed EUR 10 million, the PRRC are required to be
“permanently and continuously at their disposal” rather than “within their
organisation. Therefore, manufacturers are permitted to designate an external
subcontractor as their PRRC. In these cases, PRRC may be part of an external
organisation with which the manufacturer has established a contract laying down
provisions to ensure permanent and continuous availability of that party.
3.
Systems or procedure packs Producers
who put devices together into systems or procedure packs using devices that do
not already bear the CE marking, where the combination of devices is not
compatible with their original intended purpose, or where sterilization has not
been performed following the manufacturer’s instructions, fall under Article 22
(4). Such systems and procedure packs are treated as medical devices in their
own right; therefore, such organisations assume the obligations incumbent on
manufacturers and are required to designate a PRRC.
4.
Importers, distributors, and other
persons acting as manufacturers that market devices under their name or modify
products to impact compliance must appoint a PRRC.
5.
Authorized representatives in the EU
are mandated to ensure continuous regulatory presence by having a qualified
PRRC at their disposal.
Qualifications
of the PRRC
·
An educational background that
includes a degree in law, medicine, pharmacy, engineering, or another relevant
scientific discipline.
·
Professional Experience with at least
one year in regulatory affairs or quality management systems specifically
related to medical devices, ensuring they possess the expertise necessary for
effective compliance management or at least four years of professional
experience in relevant fields.
·
Non-EU credentials must be certified
equivalent by EU member states, utilizing platforms such as ENIC and NARIC for
validation.
Responsibilities
of the PRRC
·
Ensuring device conformity with
Medical Device and IVDR regulation standards for regulatory
compliance before market release.
·
Ensuring that technical documentation
is meticulously prepared, maintained, and updated as per Annexes II and III of
the EU MDR/IVDR.
·
Monitoring the post-market
performance and safety of devices through systematic vigilance activities,
ensuring ongoing compliance with safety standards, and identifying potential
risks.
·
Ensuring that serious incidents and
field safety corrective actions are reported to the competent authorities,
maintaining transparency and compliance with EU MDR/IVDR requirements.
·
Verifying EU declaration of
conformity is appropriately drafted and maintained, ensuring its accuracy and
adherence to regulatory requirements.
·
For investigational devices or
devices intended for performance studies in IVDs, the PRRC ensures that a
signed statement is provided by the natural or legal person responsible for
manufacturing the investigational device or conducting the performance study.
This statement must confirm that the device complies with general safety and
performance requirements, except for aspects covered by the clinical
investigation or performance study, and that all necessary precautions have
been taken to safeguard the health and safety of the subjects involved.
Conclusion
The Person Responsible for
Regulatory Compliance plays a critical role in ensuring the safety, quality,
and regulatory compliance of medical devices in the EU market. Manufacturers
must prioritize the appointment of a qualified PRRC to avoid regulatory pitfalls.
The PRRC is a regulatory formality—it’s a cornerstone of accountability. By
anchoring regulatory expertise within or closely tied to organizations, the
PRRC ensures that manufacturers uphold the EU’s high standards for medical
devices. This role protects patient safety and bolsters public trust in an
industry pivotal to global health.