With the transition in the European Union (EU) geography, from the Directives to the EU Medical Devices Regulations (MDR) 2017/745, significant changes have occurred in terms of rules and regulations. One such major change was observed in Annex I – General Safety and Performance Requirements (GSPR). In our previous blog, we deep dived into Chapter I and II. In this blog, we will analyze Chapter III and learn about additional details and Essential Requirements (ERs).
Chapter III: Requirements Regarding the Information Supplied with the Device
The chapter focuses mainly on the aspects of information supplied with the device, Instructions For Use (IFUs), labeling, Unique Device Identifier (UDI), etc. In this chapter, the changes compared to the Essential Requirements (ERs) were not primarily about altering the existing requirements, but rather focused on providing additional information and clarifying definitions. These changes aimed to address any gaps and ensure a clear understanding of the expectations.
It gives a vivid description of the legibility and clarity of the IFUs and labeling, so that the intended user can readily understand the instructions and details. Chapter III of GSPR particularly focuses on mentioning “the professionals, lay person, or other” in the texts, ensuring that the information provided caters the needs and understanding of diverse user groups.
It emphasizes heavily on the instructions to be put down in a human-readable format and can be supplemented with machine-readable information, such as Radio Frequency Identification (RFID) or bar codes. It also includes new additional information on multiple devices. If multiple devices are given to one user or location, the IFU can be provided as a single copy, if agreed upon by the purchaser. However, the purchaser has the right to request additional copies at no cost.
Additionally, Chapter III of the GSPR also addresses the provision of electronically generated Instructions for Use (IFUs), specific information to be supplied and specific requirements regarding the disclosure of residual risks through the inclusion of warnings and other relevant information. Meaning, the labeling must specify, if the device incorporates any medicinal substance, human blood, plasma derivative, tissue/cell/derivatives of human/animal origin. It should also specify in case of any carcinogenic, mutagenic, CMR substances present. It further talks about the usage of symbol and colour coding to be in line with the common specifications/harmonized standards. Further, in the case of IFU’s the GSPR now specifically mentions the clinical benefits and summary of Safety and Clinical Performance (SSCP).
Also, in case of devices incorporating electronic programmable systems (Software as a Medical Device - SaMD) the annex mentions about minimum requirements that the manufacturer should abide by, especially with respect to the areas concerning hardware IT, networks characteristics and IT security measures including protection against unauthorized access and necessity to run the software as intended.
Meanwhile, the Active Implantable Medical Devices Directive (AIMDD) did not clearly specify on the re-usable devices, specification on the user’s requirement and detailed information about any necessary preparatory treatment or handling of the device (wherever applicable), including sterilization, final assembly, calibration, and the specific levels of disinfection required to ensure patient safety, along with the available methods to achieve those disinfection levels. To know in detail about the labeling requirements under the EU MDR 2017/745, you can refer to our article focused on labeling requirements for medical devices, here.
In conclusion, Chapter III of the EU Medical Devices Regulations (MDR) introduces important changes to the General Safety and Performance Requirements (GSPR), emphasizing clear instructions, user-friendly information, and enhanced safety measures. Manufacturers and stakeholders should stay informed and ensure compliance with these updated requirements to deliver safe and effective medical devices.
Do you want to know more about GSPRs under the EU MDR? Reach out to our Regulatory experts. Stay informed. Stay compliant.