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.