European Union regulations governing notified bodies for medical devices

Abstract

The European Union (EU) Medical Device (MD) regulatory structure is transitioning from Directives to Regulations to establish safety, quality, and efficacy of MDs in the EU market. The EU Regulations have enhanced security partially by adapting stringent requirements for Notified Bodies (NBs). The Malta Medicines Authority have recently been appointed as the National Competent Authority for MDs and is interested in establishing a NB system in Malta. Guided by such information, the study aimed to analyse the main challenges presented from the transition between the Directives to Regulations governing NBs and to examine the competency of Malta to become a base for NBs. A qualitative interview with Malta Enterprise was conducted. Purposive sampling was employed whereby two members currently leading the project to attract NBs to Malta, were selected to participate. The interview covered aspects related to understanding factors in Malta which are appealing to NBs for MDs. Two meetings with aspiring NBs were attended. The meetings focused on features that are appealing in a country to favour the attraction of NBs and to comprehend why Malta could be a good candidate to establish NBs or aspiring NBs. Two computer assisted cross-sectional questionnaires entitled ‘Understanding the rationale of notified bodies NOT designated under the medical device Regulations’ (A) and ‘The hurdles faced by notified bodies DESIGNATED under the medical device Regulations’ (B) were developed. The questionnaires were validated twice by two independent expert panels. Stratified sampling was employed whereby the NBs operating for MDs were selected. All statistical analyses were conducted via Statistical Package for Social Sciences (SPSS) version 28. A total of 20 participants out of the 51 NBs enrolled and completed questionnaire A. NBs who are not yet designated under the MD Regulations were considered for this questionnaire. A total of 9 participants out of the 27 designated NBs under the Regulations enrolled and completed questionnaire B. The results highlighted that Malta is competent to become a base for NBs and one of the main struggles being faced by all the respondent NBs is the recruiting of experienced personnel.