What is Vigilance and what is its primary goal?

Vigilance is part of the post market responsibilities of the manufacturer as to continuously monitor device performance and safety. The Medical Device vigilance system is a regulatory framework designed to ensure the safety and effectiveness of medical devices by monitoring and addressing (serious) incidents. Its primary goal is to protect patients, healthcare professionals, and other users from risks associated with medical devices.  

Reporting of vigilance for medical devices 

The manufacturers are obliged to report in accordance with MDR Article 87.1 to the applicable competent authority of where the incident occurred in the event of: 

• Any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88 of the Regulation EU 2017/745; 

• Any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country. 

Or 

Any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis  referred to in section 1 and 8 of Annex I MDR and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against intended benefits as stated in MDR Article 88. 

Reporting timelines 

Manufacturers are obliged to report any serious incident immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible. A handy tool to check if the suspected serious incident is reportable, is the flow-chart in MDCG 2023-3: Q&A on Vigilance. Reporting timelines are defined in calendar days; any further specifics can also be found in this document.  

Submission of reports 

As Eudamed is not fully up and running yet, manufacturers are obliged to report to the Competent Authority of where the serious incident occurred. Additionally, any relevant forms and templates—such as the manufacturer incident report form, field safety corrective action report, or the template for drafting a field safety notice, should be utilized when needed, that can be accessed by EU Commission website here: https://health.ec.europa.eu/document/download/c1a6aa0b-d8c8-498b-8ed4-9f3c6211896d.  

Notified Body responsibilities 

Notified bodies play a crucial role in medical device vigilance by ensuring that manufacturers comply with post-market and vigilance requirements. Notified Bodies do not directly handle vigilance investigation as this is the responsibility of the competent authority in accordance with MDR Article 89.3. However, Notified Bodies are responsible for verifying compliance of the manufacturer’s vigilance procedures. The medical device vigilance system is supported by the Notified Body activity in the following areas: Assessment of the vigilance procedures, assessment of the impact of vigilance issues on the certification granted and liaise with the National Competent Authority on specific investigations/audits on a request of the National Competent Authority.  

Checks performed by the Notified Body 

When receiving vigilance information from the manufacturer, notified body will usually check: 

• if the manufacturer has a procedure for handling vigilance and if this procedure is in accordance with the regulatory requirements 

• if it agrees with the manufacturer's conclusion of the causality of the incident 

• if relevant forms and templates are attached by the manufacturer   

• if applicable, that the Field Safety Notice fulfils requirements as stated in MDR article 89.8 

• if the incident is reported in time to the competent authorities in accordance with designated timelines 

• the impact on the validity of (other) issued existing certificates  

Potential consequences 

Additionally, the Notified Body will support and liaise with the Competent Authority in its investigation. This is in cases that the risks are considered too high from the results of the evaluation of the Competent Authority in MDR Article 89.3 or the manufacturer does not cooperate with the investigation. The Notified Body can suspend, restrict or withdraw already issued certificates, raise major non-conformities or perform extraordinary surveillance review measures, unannounced audits, additional documents review or the re-assessment of design examination, when manufacturer is suspected to be not complaint.  

If the manufacturer implements a field safety corrective action by making changes to the design of the devices, production process and substantial changes should be considered and if needed reassessed and possibly recertified by the Notified Body.