Designation and oversight of notified bodies in medical device regulatory sciences

Abstract

In medical device regulatory sciences, Notified Bodies (NBs) play a crucial role for conformity of medical devices by managing and overseeing the granting of the CE marking. There are continuous apprehensions regarding the timely designation of European Union (EU) Notified Bodies. The aim of the study was the identification of challenges of designation and oversight of Notified Bodies, in medical device regulatory sciences and the development of a regulatory Guidance for competent authorities, addressing the lacuna of availability of Notified Bodies. The methodology design consisted of four phases. Phase I focused on the challenges encountered by European Union (EU) competent authorities for medical devices when designating Notified Bodies, which were identified by a reflective evaluation of the process and discussions with professionals and stakeholders. Study findings were validated in a focus group by an expert panel, who were asked to assign a reasoned rate of severity of the challenges and propose ways to overcome these challenges. Subsequently, Phase II led to a developed tool, disseminated to European experts involved with designation process of Notified Bodies. The developed tool covered three main domains with nineteen statements on: challenging timelines, setbacks encountered during designation and proposals on how to overcome these challenges. Phase III involved a comparative analysis of aspects of medical device regulation of non-EU regions with EU processes. Four sectors of medical device regulation were identified and analysed: (i) risk classification of the devices, (ii) reference market approvals from foreign countries, (iii) involvement of Independent/third party conformity assessment bodies, (iv) device nomenclature system. The final phase of this research, Phase IV, involved the development of a Guidance related to the EU regulatory scenario. The results for Phase I led to the identified challenges in the designation process, namely: quality of documents provided by the Conformity Assessment Body (CAB), efficiency in communication, timelines, time and cost associated with the CAB process, and expertise, with the latter three being classified as severe. The focus group (N=5) proposed that timelines and lack of experts were challenges which could be overcome by means of training to develop expertise in the field. The EU experts’ feedback in Phase II (N=22), on actions to overcome challenges in the designation process: 20 respondents agreeing that the corrective action and preventive action (CAPA) plan development timeline is challenging; 20 respondents agreeing that a setback encountered during the designation process is the quality of documents submitted with designation application; and 21 respondents in agreement with yearly refresher training for national expert assessors. Phase III results on the comparison analysis of the international regulatory framework indicate a harmonisation approach in most countries analysed. The Guidance developed in Phase IV comprised of six sections, with the main focus on proposals for a smooth designation process and the proposal of a Notified Body Advisory Forum (NBAF). Following the identification of challenges in the current NB designation process, this research led to the development of a Guidance which was informed by the global context and may be further evolved to ensure adequate and timely product accessibility whilst safeguarding patient quality of life.