On November 1999, the Institute Of Medicine published “To Err Is Human”, a report analyzing the mortality of people in hospitals in the United State (up to 98000 deaths) as a result of medical errors, laying out strategies to “reduce preventable medical errors”. As per this report, medical errors, more commonly “are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them.”
An ever increasing number of medical devices are being connected to hospital information networks via various types of connection (4G, Wi-Fi, Bluetooth and Ethernet). At the same time, more and more cases of issues associated with hacking, piracy and even theft of personal medical data are being reported in the media.
It is therefore appropriate to examine the current regulatory position vis-à-vis connected medical devices.
With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers.
While a continuous evaluation and improvement of the process is at the very heart of this change, the Regulations introduces more incisive and prescriptive measures based on device risk level for both the MDR and IVDR.
The Post Market Surveillance requirements are pretty similar for both the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) and are located in Chapter 7 of both regulations. Chapter 7 points out to specific Annexes describing more in detail the provisions relating to this topic.
The European Regulations on Medical Devices including Active Implantable Medical Devices (AIMD), and In Vitro Diagnostic (IVD) Medical Devices have been officially published on May 5th, 2017. Both entered into force on May the 25th, 2017.
The ISO 13485 standard represents a Quality Management System base for many regulatory schemes.
With the recent publication of the new Medical Device and In Vitro Diagnostic Regulations, the regulatory framework surrounding Medical Devices evolves and re-enforces the control of external parties (Suppliers, Subcontractors).
The newest revision of the ISO 13485 standard published in March 2016 aims in the very same direction.