The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment bodies.
The document has been already endorsed by the Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the further development of medical devices` regulatory framework. At the same time, the present guide does not provide any mandatory rules and requirements the parties involved shall follow.
The present guide describes the approach to be applied by the appropriate national regulating authorities responsible for the designation of the notified bodies entitled to conduct conformity assessment of medical devices. In particular, the document is intended to harmonize the approaches used by various designating authorities to make the designation process more consistent, transparent, and predictable. The designation procedures addressed in the guide are initially set forth by the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR). Consequently, the guide addresses the aspects related to the designation of notified bodies under the new Regulations rather than under EU Directives. The scope of the document covers only the initial designation itself, while all the matters related to further supervision are actually falling outside of its scope.
Pre-assessment of Conformity Assessment Body
According to the Regulations, a conformity assessment body interested in designation as a notified body shall submit the application form supplemented by the appropriate documentation. In the course of the application process, the applicant entity shall indicate specific activities it carries our, and also outline the particulars types of medical devices that would be covered by the scope of future designation. Upon destination as a notified body, an applicant would be allowed to conduct conformity assessment only within the scope of its designation.
The NBOG additionally emphasizes that the whole designation process could be quite lengthy and take significant time. Thus, a notified body already designated under the Directives should apply for a designation under the new Regulations in order to be allowed to carry out conformity assessment after the moment the Regulations would replace the Directives. It is recommended to commence the process in advance, approximately 18 months prior to the expected designation date. It is also important to mention that successful designation of notified bodies under the Regulations may impact the availability of medical devices – nowadays there are reasonable concerns that the number of notified bodies entitled to carry out conformity assessment under the new regulatory framework could be insufficient to process the increasing number of requests from industry representatives.
At the very first step, the designating authority would check the completeness of the application submitted and notify the applicant. In certain cases, a designating authority is entitled to find the application complete even if some documents are missing, but in this case, it would have to issue a detailed justification clarifying the reasons for the decision made. Under the general rule, the completeness check takes up to 30 days from the date the application has been received by the designating authority. Within this period, the designating authority may ask the applicant to provide additional information or documents and to indicate the timeline of the request. If despite numerous requests, the applicant fails to provide the necessary documentation, the designating authority is entitled to reject the application. In such a case, a conformity assessment body interested in designation would have to submit an application from the very beginning.
Upon receipt of a complete application, the national regulating authority would forward it to the European Commission’s Directorate-General for Health and Food Safety, Directorate F (SANTE/F) in electronic form. As it is mentioned in the guide, in case of motivated refusal the Directorate would be informed as well. In order to streamline the review process, the applicants are advised to submit all documents in English and provide the appropriate translations in case if certain documents could not be issued in English.
According to the NBOG guide, there is no pre-defined time limit for the review of the application by the designating authority, but the applicants may refer to the estimate between 3 and 8 weeks starting from the date the complete application has been submitted.
According to the applicable regulations, the designation process should include on-site assessment activities to be carried out by a team of the designating authority in accordance with the assessment plan agreed by the parties in advance. In particular, both starting and finishing times should be pre-defined and indicated in the aforementioned plan. The NBOG guide provides the following key aspects to be covered by the on-site assessment:
- Organizational and general requirements,
- Quality management requirements,
- Resource requirements, and
- Process requirements.
In order to ensure sufficient effectiveness, the designating authority team could be split into two or more sub-teams, each having a separate scope of responsibility.
Upon completion of the on-site assessment, a list of non-compliances identified would be created. All non-compliances would be divided into the appropriate categories (major or minor) depending on the impact they may cause on the results of conformity assessments or the safety and performance of medical devices. At the same time, the findings that do not contradict legal requirements would be determined as observations.
As the next step, the conformity assessment body would be asked to provide a detailed plan describing the action it would take to restore compliance and address the issues identified during the on-site assessment. The designating authority expects the conformity assessment body to provide such a plan within 20 business days from the date of completion of the on-site assessment. According to the guide, the plan should contain the following information:
- The root cause(s) of non-compliances, taking into account that often more than one cause will be the root of the deficiency,
- Corrections and CAPAs (actions) for each of the root causes identified. The designating authority also expects the applicant to indicate the timeline of such actions.
- The actions planned to verify the effectiveness of each CAPA and the timeframe for its review (e.g. internal audit, witness audits to monitor competence, etc.).
It is also important to mention that the normal process of on-site assessment could be impacted by the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus” and temporary quarantine measures and restrictions associated thereto.
The present NBOG guide also describes the post-assessment activities to be performed by the parties involved, as well as the appropriate timelines.
Summarizing the information provided here above, the new guide issued by the NBOG provides additional clarifications regarding the processes and procedures associated with the designation of conformity assessment bodies and notified bodies under the Regulations. The document describes in detail various stages, including pre-assessment and on-site inspection to be carried out in the premises of the conformity assessment body applying for the designation.
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