In the Medical Device Directive (MDD) the concepts of Vigilance and PMS were barely distinguishable. In the European Union Medical Device Regulation (EU MDR) there is a clear distinction made between; “Vigilance”; the identification, reporting and trending of serious incidents and the conduct of safety related corrective actions, and “Post Market Surveillance” (PMS); the monitoring of information from various sources used to periodically reconfirm that the benefits of the device continue to outweighs its risks. See the separate commentaries on the PMS system, PMS planning and PMS reporting.
The limited vigilance requirements of the original Directive, to notify the authorities of incidents (MDD Annex VII (4) etc.), was quickly considered insufficient by the European Authorities. Guidance was published in MEDDEV 2.12/1: Guidelines on a medical device vigilance system and regularly updated. The most comprehensive update of MEDDEV 2.12/1 was Revision 8, itself updated as recently as July 2019, together with its many standard forms and templates; Manufacturer’s incident report (MIR), Field Safety Corrective Action (FSCA) report, Field Safety Notice (FSN) template and others. It should not be a surprise therefore that the vigilance requirements in the EU MDR are largely unchanged from those in Revision 8 of MEDDEV. 2.12/1.
The vigilance requirements of the EUMDR can be found in Chapter VII Section 2 (Articles 87 to 92). The 2-day reporting deadline for serious public health threats remains unchanged from the MDD, as does the 10 day deadline for reporting a death or a serious health deterioration. However, a 15-day reporting deadline for reporting all other serious incidents replaces the MDD’s 30-day for reporting all other reportable incidents.
The EU MDR also requires vigilance reporting in the case of a significant increase in the frequency or severity of other incidents. But while trend reporting (Article 88) and analysis (Article 89) may appear to be new when compared to the MDD, again they were already required by MEDDEV 2.12/1 and have been expected by European Competent Authorities and Notified Bodies for some time.
In practice therefore, the vigilance requirements of the EU MDR are not new, but rather they bring the European legislation up to date with the current state of vigilance reporting being practiced in the EU, as defined by MEDDEV 2.12/1 Rev 8. The only truly new requirement in the EU MDR related to vigilance, is the requirement to submit vigilance reports to the EUDAMED database (Article 92), rather than to the individual national Competent Authorities as was required under the MDD. However, until the vigilance module of EUDAMED is available, the national vigilance reporting procedures will remain in place. See the separate page on EUDAMED.
Guidance
The following is a non-exhaustive list. Manufacturers should confirm the currently required documents with their Competent Authority or Authorised Representative. XML documents may also be available.
- MEDDEV 2.12/1 rev.8 Guidelines on a medical devices vigilance system
- Additional guidance on MEDDEV 2.12/1 rev.8 July 2019
- Manufacturer incident report (MIR) - as from January 2020
- Field safety corrective action (FSCA) - MEDDEV 2.12 rev. 7 FSCA remains valid
- Field Safety Notice (FSN) template
- FSN customer reply
- FSN distributor/importer reply
- Trend report
- Periodic summary report
Hello,
I have been tasked with writing a “Trend Reporting” Operational procedure for my company. Where may I find more information on what is required?
Thank you for your question.
As previously stated, many seemingly new topics in the EU MDR, although not present in the Directives, were already made requirements via MEDDEV guidance. Trend reporting is an example. Trend reporting was introduced via MEDDEV 2.12-1 and EU MDR Article 88 puts it into regulation. While MEDDEV 2.12-1 is short on detail. It does contain a Manufacturer’s Trend Report template in Annex 7.
New guidance on trend reporting has not been produced so far by the MDCG or CAMD. That might be because GHTF SG2 guidance document N54 (Global Guidance for Adverse Event Reporting for Medical Devices) already details the Authorities’ expectations for the manufacturer’s trend reporting procedure in Appendix C.
Which Company
Are we still required to trend categories of non-reportable incidents, (i.e., expected and foreseeable side effects; exceeded shelf life w failure mode not unusual; a deficiency always detected prior to use; those that have not led to death or serious injury) separately per MEDDEV 2.12-1?
Or should we now track all non-reportable incidents together, regardless of category, and set a threshold for a significant increase in the lot of them?
Thanks for any advice!
Thank you for your question about vigilance requirements after May 2020.
If your company is already placing devices on the market in compliance with the EU MDR (i.e. with an EU MDR Declaration of Conformity) it should already be following Article 88. If after May 2020 your company intends to place legacy devices on the market by taking advantage of Article 120(3), it should also follow Article 88 as a condition of Article 120(3).