Medical Device Regulations Roadmap: A Beginners Guide

Revised March 2019 to include EU MDR regulations, second edition.For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting. Many companies need to fulfil regulation from multiple jurisdictions along with Design, GMP and manufacturing requirements.This short book introduces the key themes associated with Medical Device Regulation within the EU and Europe. While the online world provides a detailed and perrinial source of current information and regulations, it is often hard to know where to start. This concise book provides that introduction in a physical format that is a useful companion for the Engineer or Medical Device Professional. This second edition also details the transition to the new EU MDR regulations. The new European regulations on medical devices and in vitro medical devices were adopted on 05 April 2017 and came into force on 25th May 2017. Both these 2 new regulations replace and repeal Council Directives 90/385/EEC, 93/42/EEC Directive 98/79/EC and Commission Decision 2010/227/EU. This short book (approx 168 pages) provides a foundation overview of the new regulations and how they are structured. It must be stated that many notified bodies and companies provide insight and guidance online, this book provides a tangible resource for day to day use or for gaining an introduction to EU MDR, or alternatively as an ongoing quick reference guide. Although adopted and in force, the new rules shall only apply after a 3-year transitional period, whereby regulations will enter into force in April 2020 for medical devices and for five years after entry into force (April 2022) for the Regulation on in-vitro diagnostic medical devices.(Page Count 168)