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.
What’s Included in the Vigilance Requirements Tool?
Where to report Serious Incidents & FSCAs
- EU Incidents:
- 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 devices on the market within the European Single Market, it must also be reported to the applicable CAs in these markets.
- MDCG Guidance 2023-3provides 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 vigilance databases that detail the FSCAs that occur in their markets. Where available, these 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 ourLanguage 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 for non-Swiss manufacturers. In this case, the Swiss Authorized Representative (CH REP) is responsible for ensuring incidents and FSCAs are reported to Swissmedic. Manufacturers may report directly; however, they must copy the CH REP into communications, at a minimum.
- The Swissmedic vigilance database is linked in the tool.
- 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 MHRA allows foreign manufacturers to report vigilance directly. While it can be, it not required that vigilance be reported by the UK Responsible Person.
- The MHRA vigilance database is linked in the tool.
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 medical device vigilance reporting.
Universal Incident and FSCA Forms
The Manufacturer Incident Report, Field Safety Correction Action Report, and Field Safety Notice Template are available using the links below.
Reporting Timelines for Incidents & FSCAs
|Type||EU and Switzerland||UK|
|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|
|All other||No later than 15 calendar days after the manufacturer became aware||No later than 30 days after the manufacturer becomes aware|
|All FSCAs||Without undue delay/immediately, defined as without any delay that is intentionally or negligently caused by the manufacturer.|