In the existing Medical Device Directive (MDD), the concepts of Vigilance and PMS were barely distinguishable. In the new European Union Medical Device Regulation (EU MDR) there is a very 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 page on PMS

The limited vigilance requirements of the MDD (Annex VII (4) etc.), to notify the authorities of incidents, have long been considered insufficient. The European Authorities real expectations are published in the Guidance document MEDDEV 2.12-1: Guidelines on a medical device vigilance system. It should be no surprise therefore that the vigilance requirements in the new EU MDR share a lot of similarities with the current MEDDEV.
The vigilance requirements of the new EUMDR can be found in Chapter VII Section 2 (Articles 87 to 92). The current 2-day deadline is retained for reporting a serious public health threat, as is the current 10-day deadline for reporting a death or serious health deterioration. However, a new 15-day reporting deadline will be introduced for reporting all other serious incidents, replacing the current 30-day requirement for reporting all other reportable incidents.

The new EU MDR will also require vigilance reporting in the case of a significant increase in the frequency or severity of other incidents. While trend reporting (Article 88) and analysis (Article 89) are new requirements compared to the current IVDD, they are already required by MEDDEV 2.12-1 and expected by European Competent Authorities and Notified Bodies. In practice therefore, the vigilance requirements of the new EU MDR are not really new, but rather bring the European legislation up to date with current vigilance practice as required by MEDDEV 2.12-1.

The only truly new requirement in the EU MDR related to vigilance will be the requirement to submit vigilance reports to a centralised pan-European database (Article 92), rather than to the individual national Competent Authorities as is currently the case under the MDD. However, this central EU database is not likely to be available before 2020 at the earliest. The implication being that national vigilance reporting procedures are likely to remain in place for a while, including for medical devices registered under the new EU MDR. See the separate page on EUDAMED.

4 thoughts on “Vigilance compared to the MDD”

  1. 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!

    1. 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).

  2. 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?

    1. 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.

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