The transition from EU MDD (2007) to EU MDR (2017) has included an increase in expectations for medical device companies in several areas. One of the key areas of intensified focus is that of vigilance, which now more clearly defined and separated from Post Market Surveillance (PMS) activities. While Post Mark Surveillance is an important part of any quality program and has been the subject of increased focus in the EU MDR (2017), vigilance represents the expectation that any serious incidents will be accurately reported and swiftly responded to.
Some of the new requirements for vigilance in EU MDR (2017) will not be surprising, as they are already included in the MEDDEV guidance document. However, there are at least two important changes to note. There is a new requirement for reporting through a centralized system and submission process. However, current expectations are that this database will not be ready until sometime in 2020. The second key change is with regards to timelines for reporting. The reporting timeline for all “serious” incidents has been moved from 30 days down to 15. This reduced timeframe reflects an overall increased focus on ensuring medical device companies are moving quickly to address reported problems and make corrections.
While not every incident reported in compliance with vigilance guidelines will necessarily result in significant action, it is important that every event be taken seriously and investigated. As always, patient health and safety is the ultimate concern.
If you have questions about the new EU MDR (2017) requirements for vigilance or need assistance developing an SOP that will comply with regulatory expectations, Medpoint can help. Our experienced consultants can provide SOP writing and review, training, and even remedial action solutions. Contact us for more information: email@example.com or 800.200.9292.