Regulations are becoming more stringent by the day, with increased safety requirements for medical device manufacturers under the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). One of the major changes introduced by these updated laws is the introduction of the Person Responsible for Regulatory Compliance (PRRC) requirement per Article 15. Now that the MDR and IVDR are in place, some noteworthy developments have occurred, which PRRCs and manufacturers need to be aware of.
This blog post will explore the basics of this role, how organisations can effectively fulfil these obligations, and highlight recent developments.
Not everyone can or should be a PRRC
With the introduction of the European Union’s MDR (2017/745) and IVDR (2017/746), the significance of a dedicated professional overseeing regulatory compliance has become even more relevant.
A PRRC is assigned to ensure that organisations address a set of specified regulatory requirements such as drawing up technical documentation, ensuring an effective Post Market Surveillance System, and producing their products in line with their Quality Management Systems. For both manufacturers and authorised representatives, it is required to have a designated PRRC available.
When assigning a PRRC, the manufacturer and/or authorised representative need to ensure that their PRRC possesses adequate qualifications and expertise in the field of medical devices or in-vitro diagnostics in the EU, meaning that they need to have:
- a) A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised 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 quality management systems relating to medical devices;
- b) Four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
The PRRC role: manufacturer vs the authorised representative
Manufacturer
Manufacturers with a staff count of over 50 employees are required to appoint at least one PRRC within their organisation, possessing relevant expertise with medical device regulations. The PRRC should be an employee of the company. Micro and small manufacturers, with fewer than 50 employees, are required to have a PRRC “permanently and continuously at their disposal” rather than “within their organisation”. It means that they have the option to rely on an external subcontractor to act as their PRRC. Larger medical device manufacturers (> 50 employees) may opt to outsource subtasks of the PRRC to external organisations, for example, performing regular audits to verify compliance of device manufacturing against the requirements set out in the manufacturer’s Quality Management System.Authorised Representative
Authorised Representatives must have a PRRC available permanently and continuously, possessing the required expertise. The manufacturer and its EU authorised representative cannot appoint the same individual to the role of PRRC.
Check out an insightful read on the role of Authorised Representative, here.
Other parties
There may be situations where organisations assume the role of manufacturer and are likewise required to appoint a PRRC.Failure to appoint a PRRC
An important consideration for manufacturers and authorised representatives is that the failure to appoint a PRRC may result in significant penalties. Due to the manner the MDR and IVDR are set up, penalties may be issued per Member State where the organisation is bringing devices onto the market. Penalties for failure to appoint a PRRC may run up to 150,000 Euro per Member State, and may even result in imprisonment (assuming for management staff) in some member states.
Key Responsibilities of a PRRC
Product Conformity per the QMS
The PRRC is responsible for verifying that all medical devices meet the requirements as set out in the Manufacturer’s Quality Management System before they are made available to the public. Practically, as a PRRC, it may be wise to execute an assessment of the device compliance before bringing devices onto the Union Market. This can involve conducting an assessment and review of the Quality Management System procedures associated with the manufacturing and development of the device’s design, manufacturing processes, and quality control measures.
Not only is the PRRC required to do so under the MDR 2017/45 and IVDR 2017/746, which may lead to non-conformities for failure to execute such tasks, but in addition, it may result in personal liability concerns for the PRRC. For example, in Italy, the legislation allows for penalising the PRRC directly, with a potential penalty of a maximum of 120,000 Euro for not executing their tasks.
Technical Documentation
The PRRC is tasked to ensure that the technical documentation is drawn up for each medical device. This documentation includes design specifications, risk assessments, clinical evaluation reports, and manufacturing details. The PRRC ensures that this documentation is accurate, up-to-date, and readily available for review by regulatory authorities, facilitating transparency and accountability. For manufacturers to demonstrate that their PRRCs have reviewed the technical documentation, it may be useful for them to have the PRRC sign off on the technical documentation.
There is no specific limitation provided within the MDR or IVDR that restricts the task of the PRRC to ensuring that only the Technical Documentation set out in Annex II and III of respective laws are present, noting that additional Technical Documentation requirements for other legislation may need to be considered by the PRRC, for example, requirements from the Machinery Regulation, the Radio Equipment Directive, and the upcoming Artificial Intelligence Act.
Post-Market Surveillance
The PRRC is further responsible for implementing and managing a system of post-market surveillance. This involves continuously collecting and analysing data on the device’s performance and safety from various sources, such as user feedback, clinical studies, and incident reports. The PRRC uses this information to identify potential issues, improve product safety, and ensure compliance with regulatory requirements.
Regulatory Reporting
PRRC needs to ensure timely reporting of incidents and corrective actions to the relevant authorities. If there are any adverse incidents or non-compliance issues, the PRRC must ensure that these are promptly reported to the appropriate regulatory authorities. This includes detailing the nature of the incident, the corrective actions taken, and the measures implemented to prevent recurrence. Timely and accurate reporting is crucial for maintaining regulatory compliance and protecting patient safety.
Compliance with EU Regulations
The PRRC plays an important role in supporting patient safety. They do so by ensuring that operations, products, and processes comply with safety-relevant aspects set out by the requirements of the EU MDR and IVDR. For a PRRC, staying informed about regulatory updates, developments in standards and guidance, and implementing necessary changes to maintain compliance is not only useful but often required. Ensuring that all regulatory documentation and processes meet the stringent standards required by the EU is essential. There are organisations the PRRC may want to enrol in to ensure they stay informed of the relevant developments, such as RAPS, TOPRA, TEAM-PRRC, Local Standards organisations (e.g. NEN in the Netherlands), Industry associations (e.g. MedTech Europe, COCIR) or EAARMED for Authorised Representatives.
How Do You Access a Qualified PRRC for Your Medical Device Company?
The PRRC ensures that medical device companies operate within the legal framework, thus enhancing patient safety and product reliability. Their role is essential in facilitating compliance with stringent regulatory standards, ultimately supporting the company’s ability to bring safe and effective medical devices to market.
Having an efficient and qualified PRRC at their disposal helps medical device companies navigate the complexities of regulatory compliance, ensuring that their products meet all necessary safety and efficacy standards.
Partnering with renowned European Authorised Representatives such as MedQAIR, who assists non-European manufacturers in meeting European legal requirements is a great way to get hold of qualified PRRCs for your compliance needs. MedQAIR offers extensive regulatory and quality expertise in medical devices and can assist manufacturers and authorised representatives in defining and establishing the PRRC role, whether internally or externally. Contact us to get help.
