With the EU Medical Device Regulation (MDR 2017/745) looming, medical device companies are focusing on ensuring compliance with the new regulations.

Within the EU Medical Device Regulation 2017/745, the essential requirements (ER) which were the core of the previous Medical Device Directive 93/42/EEC (MDD) have been replaced by the General Safety and Performance Requirements (GSPR).

One of those key aspects of compliance is to ensure your devices conform to the General Safety and Performance Requirements (GSPR).

The focus of this lecture is the Annex 1 General Safety and Performance Requirements of the new MDR 2017/745. During this lecture we will try to identify the conformity evidence to prove that you as a manufacturer of a medical device have complied with GSPR.

This lecture provides you with some practical guidance on how to meet those requirements for Software as a medical devices (SaMD) products.

Each manufacturer shall provide evidences of compliance / documentation to the GSPR.

The EU MDR 2017/745 contains 23 GSPR that are divided into three main categories that are reported in the Annex I:

Chapter 1 – General requirements (1 to 9)

Chapter 2 -Design and Manuf. (from 10 to 22)

Chapter 3 –Labels and IFU (23)

In this training session we we will list all the requirements of the General Safety and Performance Requirements (GSPR) , which International Standards applies for each requirements ,which guidance’s could be applied , documentation needed and records used as evidence of conformance with the GSPR.