CONFERENCE 2021 PRESENTATION SUMMARIES Medical Device Regulations By Ka-Mei Au
Rob Higgins is a Senior Regulatory Affairs Manager at the Medicines and Healthcare products Regulatory Agency (MHRA) and has worked there for over 30 years. Rob has experience working in medical device legislation, reviewing clinical investigations, and monitoring Notified Bodies. His main responsibilities now include conducting inspections on medical device manufacturers, the assessment of UK Approved Bodies, and being involved in global harmonisation activities. With his expertise, Rob gave an overview of the recent and upcoming changes in EU and UK medical device regulations, key considerations medical device manufacturers should be aware of, and what inspectors look for in manufacturer inspections. Background Rob’s presentation started with an overview of the existing medical device legislation in the UK which was implemented in 2002. This was based on three EU Directives: Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD) (see Figure 1). These will remain active in Great Britain until new regulations are implemented in 2023. EU MDR and EU IVDR There are two new EU medical device regulations which are replacing the existing directives in EU Member States: • EU Medical Devices Regulation (MDR) – applies from 26 May 2021 • EU In Vitro Diagnostic Medical Devices Regulation (IVDR) – applies from 26 May 2022
Figure 1. The EU medical device regulations replacing the current EU directives
The implementation of these new regulations will result in the following changes: • Updated medical device definitions and classification (see Figure 2) • A stronger post marketing surveillance system • The requirement for a person responsible for regulatory compliance – similar to a qualified person responsible for pharmacovigilance (QPPV)
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