The new 2017/745/EU Medical Device Regulations (MDR) require increased emphasis on Post Market Clinical Follow-Up (PMCF). Device manufacturers tend to equate this with post-market clinical investigations which are considered to be costly and time intensive. A potential method for acquiring cost and time effective data is the use of a device specific registry or registries developed by consortiums.
This webinar will provide an overview of PMCF requirements, outline elements of a well-designed registry and offer advice about known, potential pitfalls.
Examples of existing collaborative registries will be reviewed as a potential data source for device manufacturers.
Additionally, the presenters will discuss how registry data can be utilized in required Clinical Evaluation Reports (CER) to meet PMCF needs as required under MedDev 2.7/1, rev 4 and the new MDR.