The purpose of vigilance is to protect the health and safety of patients, healthcare professionals, and other users by reducing the probability of reoccurring serious incidents related to in vitro diagnostic medical devices. For that to happen, EU member states and their national competent authorities must be aware of any serious incidents and actions are to avoid reoccurrence.
Today, we review vigilance requirements under the IVDR, what is new, the differences in vigilance requirements between medical devices and in vitro diagnostic medical devices (IVDs), and how vigilance activities can be implemented to ensure compliance.
In Vitro Diagnostic Regulation; IVDR
Post-market surveillance (PMS) and vigilance have always been a part of the European Medical Device and In Vitro Diagnostic Device Directives.
However, with the In Vitro Diagnostic Regulation (IVDR; 2017/746), the European Commission has tightened the requirements for PMS and vigilance systems. The IVDR has compelled IVD manufacturers to set up new PMS strategies, and many scrambles to understand and interpret the new regulation.
Vigilance in the IVDR – What is new?
PMS and vigilance in the In Vitro Diagnostic Directive (IVDD; 98/79/EC) were hard to distinguish, and the vigilance process was vaguely described. However, in Article 11 of the IVDD, Vigilance procedures are recounted that member states “… shall take the necessary steps to ensure that any information brought to their knowledge [about serious incidents]… is recorded and evaluated centrally.“
In the EU In Vitro Diagnostic Regulation, however, PMS and vigilance are separated, and vigilance procedures are given their due.
Vigilance is described in Section 2: Vigilance of the IVDR. The section consists of six articles:
- Article 82 – Reporting of serious incidents and field safety corrective actions
- Article 83 – Trend reporting
- Article 84 – Analysis of serious incidents and field safety corrective actions
- Article 85 – Analysis of vigilance data
- Article 86 – Implementing acts
- Article 87 – Electronic system on vigilance and post-market surveillance
While PMS is the systematic procedure to collect and review a device’s behavior in the market, vigilance is comprised of the activities carried out when that behavior fails – identification, reporting, and trending of serious incidents, as well as the processes concerning field safety corrective actions.
Even though it may seem like the vigilance requirements for in vitro diagnostics are new in the IVDR, they were already required by MEDDEV 2.12 and thus expected by the competent authorities and notified bodies.
MEDDEV 2.12 outlines official guidelines on vigilance systems for medical devices and intends to facilitate the implementation of vigilance systems required by the medical device and in vitro diagnostic directives.
So while the vigilance process was not directly described in the IVDD, it did exist in some form in MEDDEV 2.12. Instead, the IVDR brought the European regulations up to date with the standard of vigilance reporting in the EU and added the vigilance procedure to the regulations.
One of the only genuinely new initiatives in the IVDR is the requirement to submit vigilance reports to EUDAMED instead of to each national competent authority. The system is a secure database intended to centralize and make all PMS, market surveillance, and vigilance data available to all member states and their competent authorities.
Any reports by IVD manufacturers on serious incidents, field safety corrective actions, periodic summaries, field safety notices, and trend reports must be uploaded to EUDAMED to be documented and processed.
What are the differences between vigilance for medical devices and IVDs?
The differences in vigilance requirements between medical devices and in vitro diagnostic devices lie in the logistics and definitions, not in the process itself. IVD manufacturers are required to inform the national competent authority of any action taken to reduce the risk of harm or severe health deterioration, such as FSCAs (Field safety corrective actions), within the established timelines – precisely the same as manufacturers of medical devices.
The deadlines for reporting severe incidents are also the same between the two regulations:
- Serious threats to public health must be reported to the authority in no more than two days
- Death or serious deterioration of health must be reported in no more than ten days
- Serious incidents must be reported in no more than 15 days
The differences between the two regulations can be found in the minor details of the requirements, such as the specific content of the different reports. It depends on your device type and risk classes.
At this point, the significant difference between the Medical Device Regulation (MDR; 2017/745) and the IVDR is the roll-out of each regulation. The MDR came into force in May 2021, while the IVDR began implementation on May 26th, 2022.
Moreover, the certifications of notified bodies (NBs) are struggling to keep up with medical device notified bodies in terms of conformity assessment demands for IVDs.
One of the most critical points of compliance with the IVDR is executing a successful transition strategy. Manufacturers will need to update their existing standard operating procedures (SOPs) or develop new ones to ensure compliance. After establishing a cross-functional expert team to handle the transition, a gap assessment is needed to identify any issues with compliance. Furthermore, prioritizing device portfolios and quality management system (QMS) processes is recommended for manufacturers of more than one device.
Technical file updates
Once a transition strategy has been established, blank spots in the compliance records and technical file should be addressed. This could be anything from implementing processes for periodic safety update reports and summaries of safety and clinical performance to updating the design history file and the device master record to gathering data and uploading it to EUDAMED. Only by updating the needed documentation can conformity assessment be achieved.
The MDR and IVDR made significant updates to the regulation of medical and in vitro diagnostic devices in the European market. Most new requirements were already present in the previous regulation or official guidelines. However, the updated regulations concreted the requirements and brought the regulations up to date with the industry’s standards. Vigilance requirements for IVDs have never been stricter, but they have never been more apparent.