The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities focused at the improvement and harmonization of the regulatory framework, issued guidance dedicated to the assessment methods to be used by regulating authorities for recognition and surveillance of medical device conformity assessment bodies.
The document is dedicated to the way the regulating authorities should assess the compliance of conformity assessment bodies with applicable requirements. In particular, the document describes the requirements applicable to designated bodies responsible for the conformity assessment of medical devices. The regulatory approach, in general, is based on the principle of finding an optimal balance between ensuring the highest level of patients` health protection and determining the appropriate regulatory burden for the conformity assessment bodies. Thus, the document outlines the requirements the conformity assessment bodies should meet in order to be eligible to perform their functions regarding the medical devices falling within the scope of designation.
First of all, the document provides an overview of the relationships existing in the spheres of medical devices conformity assessment, describing in detail the particular functions of each participant, namely:
- The manufacturer of a medical device applies for premarket approval.
- The Conformity Assessment Body:
- Reviews the documents and samples provided by the manufacturer,
- Issues recommendations regarding the submission,
- Under certain conditions issues a certificate.
- The regulating authority:
- Designates conformity assessment bodies allowing them to perform conformity assessment,
- Issues final decisions regarding the submission on the basis of the information and recommendations provided by the conformity assessment body,
- Issues a certificate.
The participation of the conformity assessment body in the process covers the initial regulatory review. According to the document, in some cases, the regulating authority will make a final decision regarding the marketing approval of a medical device in question on the basis of the information provided by the conformity assessment body.
The document also provides definitions for the most important concepts described therein including, inter alia, the following ones:
- Quality Management System (QMS) covers the scope of activities by which the entity determines its objectives and processes necessary. This approach is used by the management of the entity to use the resources available in an optimal way.
- Technical Documentation – the documents that provide evidence of compliance with the Essential Principles of Safety and Performance of Medical Devices any device should comply with.
One of the most important concepts described in the document is an Assessment Cycle that constitutes the approach the regulating authority utilizes when performing its functions regarding the particular conformity assessment body. According to the document, an Assessment Cycle includes the following consecutive steps:
- Initial Assessment.
- First Surveillance Assessment.
- Second Surveillance Assessment.
- Third Surveillance Assessment.
- Re-Recognition Assessment.
It is important to mention that each step stands for one year. In accordance with applicable legislation, the length of a cycle may vary, but in any case, it should not exceed five years. After the 5th step “Re-Recognition”, the whole process starts again from the second step “Surveillance Assessment”.
The concept of the Assessment Program describes the whole process more precisely. Each of the steps includes certain important elements, namely:
- Initial Assessment includes an application review, documentation review, on-site assessment (including an additional one for critical locations), and Marketing Review Assessment (MRA).
- Surveillance Assessment step includes surveillance on-site assessment (including an additional one for critical locations), and MRA.
- Re-Recognition Assessment includes documentation review, re-recognition on-site assessment (including an additional one for critical locations), and (MRA).
It is also allowed to modify the Assessment Program due to the particular situation, so the decision on the way it should be applied should be made on a case-by-case basis. When developing a plan of the assessment process, the regulating authority should take into consideration certain important aspects, such as the information on the past performance of the conformity assessment body, especially related to the results of assessments that took place before and the nonconformities identified; change control; core procedures performed by the assessment body; and also the analysis of marketing submissions for medical devices, both reviewed by the particular conformity assessment body in question or for other similar medical devices.
The document also describes the distribution of functions and roles among different participants of the assessment process. In particular, the document states the following:
- The Assessment Team should conduct the assessment itself; issue recommendations regarding the designation, changes to the way the Assessment Program should be implemented, and also the locations and samples to be reviewed; reviews the responses provided by the conformity assessment body and approves them.
- The Assessment Program Manager should communicate with the conformity assessment body to collect all the information necessary for the evaluation, and also notify the assessment body on all updates regarding the process; develop an Assessment Program and ensure it is fulfilled; provide the members of the assessment team with all the information they may need; review the results of the assessment and issue the final recommendations.
- The Regulating Authority should approve the implementation of the Assessment Program and make a reasonable decision on the recognition.
Assessment Steps in Detail
According to the guidance, each of the steps has a definite purpose.
- The Initial Assessment is intended to form the Assessment Program plan to be used and to evaluate the compliance with applicable requirements.
- The Surveillance Assessment is intended to ensure that the conformity assessment body duly maintains compliance with the requirements.
- The Re-recognition Assessment is intended to ensure that all requirements allowing the regulating authority to renew the recognition are met.
The scope of designation (recognition) of the conformity assessment body describes the categories of medical devices it is entitled to evaluate in the course of submission review.
The whole process starts with the application review when the regulating authority evaluates the information provided in the application by the conformity assessment body applying for designation to determine whether it is sufficient.
During the Stage 1 Assessment, the regulating authority reviews the documentation regarding management system to evaluate its compliance with applicable requirements, collects additional information to define the types of medical devices to be covered by the scope of designation, identifies the locations and site-specific conditions, evaluates the internal audits, the structure of the conformity assessment body, its management and operations to develop the Assessment Program plan, and other elements.
The Stage 2 On-Site Assessment takes place at the main business location of the conformity assessment body applying for the designation.
The On-Site Assessment at Critical Locations includes the assessment of other locations that were not covered in the previous step in case if it is reasonably necessary.
The Marketing Review Audit includes the evaluation of the competence of the employees of the conformity assessment body, and also the methods used by the appropriate body when evaluating the submissions subject to review. During this step, the regulatory authority also assesses the decisions on a certification made by the conformity assessment body.
Summarizing the information provided hereabove, the guidance provides a step-by-step description of the process to be performed by the regulating authority in order to assess the compliance of the applicant with the requirements to be met to be eligible for the designation.
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