The new article describes the matters related to the re-assessment of designated conformity assessment bodies.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical device regulations, has published a guidance document dedicated to conformity assessment bodies (CABs) and notified bodies (NBs). The document describes in detail the aspects related to their initial assessment and designation, including on-site inspections and all the regulatory procedures to be performed by the parties involved in the course of designation. The scope of the guidance covers, inter alia, the re-assessment of duly designated conformity assessment bodies.
It is also stated that the document should not be construed as representing an official position of the EC, and is not binding. Thus, the guidance is not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory requirements and explain the way they should be followed.
Re-assessment: Key Points
Under the general rule, the procedures to be followed in the course of re-assessment of notified bodies are similar to the ones conducted during the initial designation. At the same time, there are certain differences, which are described in detail in the present guidance. For instance, there are specific time limits for such an assessment set forth by the applicable regulations. The reason behind the introduction of the said limits is the fact that the entity subject to re-assessment also undertakes certain activities in the field of medical devices, hence, it is vitally important to ensure it complies with any applicable regulatory requirements.
Documentation for Re-assessment
First of all, the MDCG mentions that notified bodies are obliged to submit information and documentation demonstrating compliance with the applicable regulatory requirements. The scope of such documentation should cover the activities a notified body undertakes, and also indicate the specific medical device types falling within the scope of designation. Apart from that, the documentation should include:
- A list of certificates held by the NB,
- A copy of the matrix detailing the authorizations and responsibilities of the personnel in respect of conformity assessment activities,
- The quality management system documentation, including the management system structure and the list of all quality management system documents, and the sequence and interrelation of processes.
It is further explained that the notified bodies should consider the timeframes for the assessment of the documentation they are expected to provide, as well as the subsequent on-site inspection and other activities to be performed in the course of re-assessment. In this respect, the MDCG recommends submitting the aforementioned documentation from 3 to 6 months before the notified body becomes eligible for re-assessment.
Once the documentation described herein above is received by the designating authority, the latter will assess its completeness as the very first step. Under the general rule, the completeness check should be performed within 30 days from the date the documents were initially received. Should it be identified that certain information is missing, the notified body subject to re-assessment would have to provide such information within the said 40 days. The designating authority conducting a re-assessment may also set forth a specific timeline for the missing information to be provided.
Should it appear that after a few rounds of interactions the information provided by the notified body is still incomplete, the designating authority is entitled to terminate the reassessment process?
Upon successful completion of the completeness check conducted to ensure that all the documentation is in place, the designating authority will commence the substantial review of the reassessment documentation. Such a review will be performed following the internal procedures developed and implemented by the designating authority. In the course of the assessment, the designating authority will take into consideration corresponding provisions of the Medical Device Directive 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Directive 2017/746 (IVDR), as well as any other applicable regulations, together with the results of monitoring and assessment activities performed earlier by the designating authority. The results of such a review will be documented in the form of the preliminary re-assessment report (PRAR).
At this stage, the designating authority is also entitled to request the notified body subject to re-assessment to provide additional information reasonably needed to complete the documentation review or ask for clarification. It is important to mention that such requests would have a predefined timeframe for response.
Once the PRAR is completed and submitted to the authority, the joint assessment team (JAT) will be appointed, and the on-site assessment will be scheduled.
The same as in the case of initial designation, an on-site inspection will be conducted to verify compliance with the applicable regulatory requirements, and the procedures to be followed are quite similar. As further explained by the MDCG, the scope of an on-site assessment to be led by the designating authority and joined by the JAT will cover such aspects as:
- The NB’s quality management system documentation;
- Reviews of NB conformity assessment activities, including assessment of technical documentation and clinical documentation by Article 45(4) of the MDR and Article 41(4) of the IVDR, including the (related) NB’s personnel files, and
- Any other applicable requirements of these Regulations.
The authority also mentions that the assessment would also cover any changes to the quality management system of a notified body introduced after the initial designation (or last re-assessment).
Upon completion of all the procedures related to an on-site assessment and post-on-site assessment activities which are in general following the respective procedures to be performed in the course of the initial designation, the designating authority will prepare a final re-assessment report that should contain:
- The designating authority’s conclusion on whether or not the NB still satisfies the relevant requirements of the MDR/IVDR, and
- Where applicable, a recommendation on an amendment to the NB’s scope of designation, including any conditions and sufficiently detailed information in case the newly recommended scope differs from the NB’s scope of designation.
In summary, the present guidance describes in detail the regulatory processes and procedures related to the re-assessment of notified bodies. The document provides additional clarifications regarding the actions to be taken by the parties involved and also outlines the differences in comparison to the initial designation process.
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