General Safety and Performance Requirements

Roger Gray, Member of the Board, EAAR; Vice President, Quality and Regulatory, Donawa Lifescience Consulting, Italy

One of the foundations of the European approach to medical device regulation is the establishment of certain ‘Essential Requirements’ (ERs) to which manufacturers must demonstrate compliance before a device can be CE marked and placed on the European market. The current medical device directives, AIMDD (90/385/EC), MDD (93/42/EEC) and IVDD (98/79/EC) all include ERs relevant to the device type concerned, but now these directives are being replaced by the Medical Devices Regulation (MDR, (EU) 2017/745) and the In Vitro Diagnostic Device Regulation (IVDR, (EU) 2017/746). Both of these impose significantly increased regulatory control on device manufacturers, with greatly expanded texts over their predecessor directives.

It is no surprise, therefore, that the ERs have grown in size, and also acquired a new name: ‘General Safety and Performance Requirements’ (GSPRs). The MDR and IVDR GSPRs are almost twice as long as the MDD and IVDR ERs respectively, with an expansion from 13 to 23 sections in the MDR, and 8 to 20 sections in the IVDR.

So what has changed? This session will explore the major additions and revisions from the ERs to the GSPRs, concentrating on the MDR, with emphasis on the impact of the changes for device verification and validation. These changes will need to be carefully considered by manufacturers when transitioning legacy devices to the new regulations, as well as when introducing new devices.