IMDRF Regulatory Authority Assessors: General Principles
The present document issued by the IMDRF is focused on the improvement of the marketing review process. It is intended to establish the basic requirements for the conformity assessment bodies – special entities designated by the national regulating authorities to review the premarket applications on medical devices within the scope of their designation. In particular, the document describes the approach to the recognition and monitoring of CABs. The requirements highlighted in the document should be implemented by the national regulating authorities performing designation of notified bodies (depending to the particular country and jurisdiction, it could be referred to as “notification”, “registration” or “accreditation”, each meaning the same process of recognition providing that the particular entity is entitled to perform conformity assessment of medical devices.
The document from the IMDRF is dedicated to the competence and training requirements to be met by the specialists performing the assessment of CABs. The scope of the document covers the following aspects:
- Knowledge, skills and abilities,
- Competence degrees and applicable criteria,
- Evaluation and development of assessors – specialists of regulating authorities involved in assessment procedures,
- Training of assessors.
The requirements described by the IMDRF in the document are intended to deal with inconsistency and ineffectiveness that could take place in the assessment of CABs. According to the requirements, the assessors should demonstrate the appropriate competence to be allowed to perform assessment procedures and make decisions regarding the designation of entities.
In particular, the scope of the document covers the following key function roles:
- Recognition Manager:
- Performs the initial review of the applications for designation, defines the requirements necessary for the assessment team, forms the appropriate team and sets forth the terms of assessment.
- Makes decisions on the approval of the assessment results.
- Lead Assessor / Assessor:
- Performs the assessment of the management system employed by the conformity assessment body.
- Lead Assessor / Assessor:
- Performs the assessment of the competences of the conformity assessment body.
- Performs the assessment of compliance of the conformity assessment body with the regulatory requirements.
In accordance with the definition provided in the document from the IMDRF, a Technical Expert is a person providing consultations on an ad hoc basis. Depending on the particular situation, an Expert could be either an employee of the regulating authority or an independent third-party expert with the appropriate qualification needed to address the particular issue.
The national regulating authority should collect evidence confirming that its employees performing the assessment procedures conducted in the course of designation comply with all applicable requirements. In particular, the sphere of responsibility of the national regulating authority covers the following aspects:
- Initial qualification, skills, and competences of the employees,
- Ensuring that the employees performing the assessment procedures maintain compliance with applicable requirements,
- Ensuring that the employees obtain all necessary support and resources,
- Properly documenting the participation of each particular employee in the designation procedures.
The regulating authority shall also ensure the awareness of any potential conflicts of interest.
Basic Requirements for Assessors form the IMDRF
The criteria and requirements described in the document, from the IMDRF, should be used by the regulating authority when performing the selection and training of the employees engaged in assessment procedures. In particular, the requirements cover such aspects as education, experience, and competences.
- Requirements on education: the employees involved in assessment procedures should hold a bachelor`s degree in one of the following spheres: health, science, medicine, engineering, or another relevant sphere. All further development should be based on the educational background. At the same time, in certain cases, it would be sufficient to confirm the appropriate knowledge without holding the university degree, providing that the authority would duly document the grounds for such a decision.
- Requirements on experience: the experience of key persons listed hereabove should be sufficient to fulfill their professional duties. In particular, it should include not less than 4 years of practice in the appropriate sphere while advanced qualification degrees could substitute only 3 years of experience. However, the experience in other spheres or with a shorter duration could be also acceptable under certain conditions. To be eligible for such exclusion, the person applying for the key function role position should demonstrate in-depth knowledge in the sphere of medical devices and regulatory compliance.
- Requirements on competences. The persons applying for key function role positions should have the foundational, functional and technical competences. Foundation competencies include adaptability, proper attitude, communication skills, critical and analytical thinking, cultural sensitivity, integrity, interpersonal skills, objectivity, perception and tenacity. Functional competencies include autonomy, adherence to the proper performing of business processes, conflict resolution skills, project management and records management skills and other elements. The scope of technical competences covers such aspects as knowledge of regulatory requirements applicable to medical devices, being familiar with the medical devices sphere in general, including the safety and risks associated with their use. These competencies should be evaluated at the very first step. In case if such evaluation is not reasonably possible, the authority should complete the evaluation before the person in question would actually participate in assessment procedures. It is also required to evaluate the competences on a regular basis, duly documenting such evaluation.
The document, from the IMDRF, also provides a detailed description of the particular approach to be applied by the regulating authority when evaluating the competencies the key function employees should have.
Requirements for Training
Besides the requirements on competencies, the document also describes the requirements on the training of the employees to be performed by the regulating authority. The programs of such training should be developed in accordance with the corresponding competences. In particular, the authority should perform the following training activities:
- Mandatory initial training dedicated to the entirely new or amended requirements failing outside of the scope of the previous training of the particular employee.
- Maintenance training performed to assist key function persons in maintaining their knowledge. In particular, this type of training should be focused on the most important changes to the regulatory framework, and also to the changes to the internal rules regulating assessment procedures and all processes associated thereto. It is important to mention that this type of requirement should not be applied to the technical experts since they are involved on an ad hoc basis.
- Continual Professional Development (CPD). Employees occupying key function role positions should make efforts aimed at continuous improvement of their skills and knowledge. This should include at least 6 hours of professional development and 8 hours of training dedicated to regulatory requirements and amendments thereto per year.
Summarizing the information provided hereabove, the document issued by the IMDRF describes the requirements on competences and training the assessors performing the assessment of CABs should meet.
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