The second vigilance pathway of the MDR - Art. 88 Trend reporting

Until now, most companies have only had to deal with serious incident reporting - from 26 May 2021, a second reporting pathway is added for all companies.

Trend reporting - what is new?

Trend reporting itself already existed as a concept in the pre-MDR world, but most manufacturers had not really paid attention to this and it was also often not required and checked by the regulatory side. As early as 2003, the former GHTF (now IMDRF) published guidance on the subject entitled "Manufacturer's Trend Reporting of Adverse Events" by Study Group 2.

Vigilance reporting for every manufacturer

Art. 88 of the MDR at least picks up the name "Trend Reporting" and thus establishes a second way of vigilance reporting inevitably for EVERY manufacturer. What this means for you as a manufacturer is explained below.

When reporting trends, the MDR requires the manufacturer to find a way to detect "...any statistically significant increase in the frequency or severity of NON-SERIOUS INCIDENTS or EXPECTED UNDESIRABLE SIDE EFFECTS..." that could have a significant impact on the benefit-risk analysis AND that will lead OR could lead to risks to the health or safety of patients, users or others that are NOT ACCEPTABLE given the intended benefits.

To this end, each manufacturer will need to describe in their PMS plans under Article 84 exactly what methodology and means they will use to generate these data.

The difficulty will be to generate a data flow from the field for NON-SERIOUS INCIDENTS, as these data are often not reported (Reactive PMS). Manufacturers thus need to establish a proactive way to get this data as well, e.g., through market surveys.

If the manufacturer receives this data, a system must be implemented at the manufacturer that can evaluate and assess this type of data. For this purpose, it is necessary to have implemented robust feedback handling in the quality management system and to have established an adequate link to risk management. Furthermore, the manufacturer must be able to determine a baseline (estimated value) for the frequency and severity of certain risks for each product or product family in order to be able to determine a statistically significant change. What does statistically significant even mean in an individual case? Over which period of time?

A complex topic - we support you

The topic is very complex, as it requires different processes to communicate with each other and the determination of the assessment parameters is very individual.

If you need support on this topic, please feel free to contact us - we will bring light into the darkness.