Regulation of medical devices in Europe and Africa

Abstract

The spectrum of medical device regulation worldwide is diverse. The safety of the patient takes centre stage whenever updates are made to any regulation. In Europe, the Medical Device Directives were reviewed due to scandals like the one that involved leaking silicone breast implants that contained a different grade of silicone than was initially approved. This led to the development of the Medical Device Regulation (EU 2017/745- MDR), which due to the corona virus pandemic will come into force in May 2021 and not May 2020. Africa does not have a standard medical device regulation. Many countries in Africa do not have country specific medical device regulations and implement varied regulatory practices. The purpose of this study was to evaluate the regulations and guidelines for medical devices in Europe (Germany and Switzerland) and five countries in Africa, namely, Uganda, Kenya, Tanzania, Rwanda and Ghana with the aim of identifying gaps and proposing strategies for improvement. A questionnaire was administered to 15 regulatory officers and a key informant guide used to interview 5 key informants. Questionnaires were self-administered and the key informant interviews conducted via telephone, skype and face to face. Data analysis of audio interviews, transcripts and notes based on qualitative thematic content was conducted and reviewed for consistency for qualitative data. Questionnaires were used to carry out quantitative data triangulation of the interviews. Challenges reported by the participants included inadequate staff numbers which was common to all the African authorities, existence of an imbalance between pre-market approval and post market surveillance with more emphasis being placed on pre-market activities. Neglect of post market surveillance due to lack of funds to conduct related activities. Perception on the robustness of the medical device regulation was mixed, for example, Tanzania reported that the regulatory system is not robust enough to guarantee medical device safety, effectiveness and quality as inspection of manufacturing facilities is not done and the approach applied was based on the pharmaceutical regulatory framework. The African countries that took part in this study have undertaken several measures including formulation of regulations where none exist, revisions to medical device regulations to cater for advances in technology and categories of medical devices not taken into consideration at the time the regulations were developed, recruitment of qualified staff and a harmonization drive through the Pan African Harmonisation Work Party to develop a standard regulation for medical devices. The results of this study provide a current picture and better understanding of the status of medical device regulations and guidelines applied in Europe and the selected African countries. Regulation of medical devices in Africa is limited and the participating African countries were at different maturity levels with respect to existence of medical device regulation, guidelines and actual practice. Out of the 5 African countries that participated, 3, namely, Kenya, Rwanda and Uganda lacked regulations. The absence of a regulatory framework for medical device regulation in the 3 countries implies that the scope of regulation is ill defined. Harmonisation efforts for medical device regulation are in the early stages implying that the development of a standard regulation lacks a defined timeline. This thesis could contribute to advances in medical device regulation as the results demonstrated that the ground is fertile for the development of regulations where none exist, can contribute towards harmonization efforts and aid in adoption of improvements in regulation where they exist. This will bolster regulatory efforts and contribute towards patient access to safe and effective medical devices of good quality.