MEDICAL DEVICE REGULATION MDR (EU 745/2017)

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS GSPR, Annex I - A section by section overview

De: E. Smith

Narrado por: Virtual Voice

This short publication book covers Annex 1 General Safety and Performance Requirements , Annex I, (GSPR) of MDR 745/2017 in detail encompassing
Chapter I General Requirements,
Chapter II Requirements Regarding Design And Manufacture and
Chapter III Requirements Regarding the Information supplied with the device.
Commentary is provided on each section and where necessary, further information is supplied in the appendices.

The Safety and Performance of medical devices must be a factor from the conception stage of a product through its development, verification validation, manufacturing and to eventual commercialisation. Performance and safety requirements are necessary to deliver products that meet the intended use and provide the desired outcomes for patients and end users. These requirements begin as stakeholder needs. Where upon assessment they manifest themselves as design inputs and design requirements have a product.
The inception of Safety and Performance requirements may seem obvious or expected, however, it goes beyond mere stakeholder needs or good practice as safety and performance requirements ensure patient safety is at the core of design and manufacturing. The application of regulation and appropriate legislation also requires performance and safety is demonstrated prior to approval and through a products lifecycle. Therefore, by placing safety and performance front and foremost, better design processes and outcomes can be achieved during product registration on submission and through the ongoing process of post marketing surveillance and regulatory oversight. 745/2017 (EU) MDR specifies general safety and performance requirements which need to be demonstrated by the manufacturer in relation to products. In addition, competent authorities throughout the world mandate safety and performance requirements as part of legal registration and also per local regulations. Safety and Performance must be accounted for in:

• Both the design activities and manufacturing stages
• Under normal conditions of use
• Safety of the patient but also any users associated with its operation
• Application of risk principles to determine acceptable risks versus the benefit

It should be noted to the reader that the text of the EU MDR regulation is freely available for download and review online. However, this publication seeks to provide a readable resource that can supplement the reader as they interpret the regulation and its expectations on the manufacturers processes and documentation.
Please note: Text From Regulation (EU) 2017/745 Of The European Parliament And Of The Council of 5 April 2017 in this book is in the public domain and is included in compliance with the European Union’s reuse policy and is based on Decision 2011/833/EU and is referenced and identified.
Refer to this link for reuse policy once acknowledgement of the source is provided.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32011D0833