Vigilance Requirements Tool
Manufacturers are responsible for assessing any incidents that occur with their products on the market and determining if the incidents require reporting to a Competent Authority.
Until EUDAMED (the EU medical device database) is fully functional, manufacturers are responsible for notifying the relevant Competent Authorities directly of serious incidents that occur and any related Field Safety Corrective Actions (FSCA) taken. Similar notification requirements also exist for the United Kingdom and Switzerland.
Our tool helps you keep track of the contacts for these vigilance notifications, and the general process to report, in 33 markets.
Vigilance Requirements Tool Features:
- Provides vigilance contacts for the EU-27, Iceland, Liechtenstein, Norway, Turkey, the United Kingdom (England, Scotland, Wales, and Northern Ireland) and Switzerland
- Outlines the process to notify each Competent Authority of reportable incidents and FSCAs
- Confirms if there is a public Field Safety Notice (FSN) database available in each market and if so, the link
- Provides helpful links and citations to each Competent Authority (CA) website and any applicable forms
Casus reviews this data annually. The most recent review date is posted below the search selection options.
JUMP TO VIGILANCE REQUIREMENTS
The vigilance requirements provided below are for reference only. Casus Consulting does not take responsibility for the accuracy of this information. Casus Consulting has taken due care in preparing the vigilance requirements tool, but we do not guarantee, nor do we assume legal liability or responsibility for, the accuracy or completeness of the information contained in these materials.
The vigilance requirements are publicly available on each Competent Authority website. Links are provided in the tool and individuals should verify the information as published by the Competent Authority before taking any action. Further, if there is a question on a specific requirement, Casus suggests reaching out to the Competent Authority directly to confirm.
Where to report Incidents and FSCAs
- EU Incidents:
- Manufacturers are responsible for assessing if an incident is considered serious per MDR Article 2(65)/IVDR Article 2(68) and is therefore reportable. Where an incident is determined to be reportable, it must be reported to the Competent Authority (CA) in the market where the incident occurred.
- If there is a question if an event is reportable or not, manufacturers should err on the side of reporting.
- EU FSCAs:
- For FSCAs, the manufacturer must notify the CAs in all member states where the FSCA is being conducted. This means, all countries where the devices/device lots affected by the FSCA are on the market.
- Further, the Competent Authority in the market where the manufacturer or its Authorized Manufacturer is based must also be informed.
- If an FSCA is being undertaken in a third country, and it affects the devices on the market in the EU-27, Iceland, Liechtenstein, Norway, and Turkey, it must also be reported to the applicable CAs in these markets.
- MDCG Guidance 2023-3 provides an example of when this would be necessary: A recall of a device has taken place in a third country due to a malfunction with certain lots. If the lots affected by this recall have also been made available on the Union market, then all relevant competent authorities must be notified of the FSCA.
- Manufacturers must also communicate the FSCA to device users through a Field Safety Notice (FSN). Many Competent Authorities have public FSN databases that detail the FSCAs that occur in their markets. Where available, these FSN databases are linked below.
- FSNs must be translated into the official language or languages determined by the Competent Authority in each market. The official languages can be found in our Language Requirement Tool. As FSNs may still be targeted to a layperson end-user, even for professional use devices, many CAs impose similar requirements for both professional use and layperson use devices.
- Switzerland generally follows the same reporting requirements noted above for the EU. The main difference is that incidents and FSCAs must be reported by the Swiss Authorized Representative in cases where the manufacturer is not based in Switzerland, i.e., they cannot be reported directly by the foreign manufacturer.
- United Kingdom
- The current UK regulations (UK MDR 2002) are based on the previous EU Directives. Therefore, the applicable vigilance guidance is MEDDEV 2.12/1 rev.8.
The European Commission (EC) maintains a list of vigilance contacts for all the EU-27, Iceland, Liechtenstein, Norway and Turkey. Most Competent Authority websites further specify which of these contacts should be used when emailing vigilance reports, which may not always be all contacts listed on the EC Vigilance contact list.
Our tool includes all the email addresses for vigilance contacts on the EC’s list; plus, we highlight the specific contact that the Competent Authority states should be used for vigilance reporting.
The Switzerland and UK contacts included in the below tool are based on the contacts listed on Swissmedic’s and the MHRA’s respective websites.
Universal Incident and FSCA Forms
Reporting Timelines for Incidents and FSCAs
EU and Switzerland
Serious public health threat
|No later than 2 calendar days after the manufacturer becomes aware|
Death or unanticipated serious deterioration in state of health
|No later than 10 calendar days after the manufacturer becomes aware|
Any serious incident
|No later than 15 calendar days after the manufacturer became aware||Not applicable in UK Regulations|
|Not applicable in EU or Swiss Regulations||No later than 30 calendar days after the manufacturer became aware|
|Without undue delay/immediately, defined as without any delay that is intentionally or negligently caused by the manufacturer.|
Last Reviewed: April 2023