Shalinee Naidoo How to classify your medical device under European Regulations

Annotation

Over the last 20 or so years, the number, range, and complexity of medical devices available on the market has increased drastically and as a result, so has the complexity of the regulations involved. With new and emerging technologies as well as various well-known incidents within the medical device industry, the current regulatory framework has since been challenged. In fact, many gaps and scarcity of skills and expertise have been identified. For this reason, there was an increasing need to update the current Medical Device Directive (MDD 93/42/EEC) in the European Union, which in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe with specific focus on classification methods. It looks specifically at how to class a medical device based on the risk associated with it as well the details around the European Classification Systems provided in the MEDDEV 2.4/1. This volume also delves into the detail around defining borderline medical devices and how they are classified according to the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices as published by the European Commission.