Timely Designation Of Notified Bodies Within The European Union

• By: FARRUGIA, Karen (Faculty Of Medicine And Surgery, University Of Malta, Malta)
• Co-author(s): Ms Karen Farrugia (Department of Pharmacy, Faculty of Medicine and Surgery, University Of Malta, Msida, Malta / Medical Devices and Pharmaceutical Collaboration, Malta Medicines Authority, San Gwann, Malta)
  Dr Alison Anastasi (Department of Pharmacy, Faculty of Medicine and Surgery, University Of Malta, Msida, Malta)
  Dr Louise Grech (Department of Pharmacy, Faculty of Medicine and Surgery, University Of Malta, Msida, Malta / Medical Devices and Pharmaceutical Collaboration, Malta Medicines Authority, San Gwann, Malta)
  Prof Lilian M. Azzopardi (Department of Pharmacy, Faculty of Medicine and Surgery, University Of Malta, Msida, Malta)
  
• Abstract:

  Background
  Notified Bodies play a crucial role for conformity of medical devices. The change in the European Union (EU) legislation aimed at providing a more robust and transparent harmonised regulatory framework, ensuring better safety and quality of devices. According to the new legislation, the designation process of Notified Bodies by the designating authorities is lengthy and of increased scrutiny. There are continuous apprehensions regarding the timely designation of Notified Bodies. The current few numbers of Notified Bodies are creating a bottleneck situation which could inevitably result in a backlog of medical device compliance assessments, limiting the availability of medical devices.
  Purpose
  To identify challenges of designation of Notified Bodies in medical device regulatory sciences through discussions with experts and capturing the perceptions and expectations of EU authorities in the field, with resulting proposals to overcome the identified setbacks.
  Method
  Challenges encountered by European Union (EU) competent authorities for medical devices when designating Notified Bodies were identified by 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, a tool was developed and disseminated to European experts involved with designation process. 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.
  Results
  The identified challenges in the designation process were: 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 both timelines and lack of experts were challenges which could be overcome by means of training to develop expertise in the field. The response received from the experts (N=22), 20 respondents agreed the corrective action and preventive action (CAPA) plan development timeline is challenging, 20 respondents agreed a setback encountered during the designation process is the quality of documents submitted with designation application and 21 respondents agreed yearly refresher training for national expert assessors could overcome the challenges in the designation process.
  Conclusion
  Insights from this study into the European Union (EU) process and resulting European Union (EU) experts’ evaluation on ways to overcome the setbacks mostly affecting timely designation of conformity assessment bodies, is contributing to the development of a framework that could be taken up by European Union (EU) member states for a smooth designation process, guaranteeing an uninterrupted continuity in the supply of medical technologies to patients and healthcare systems in the European Union (EU).