Article 88

This article refers to the close monitoring required for devices in the market. It discusses the monitoring of incidents in the market before they become serious incidents.

The Manufacturer’s Role

Manufacturers must report statistically significant increases in:

• Frequency or severity of incidents that are not serious incidents; and
• Expected undesirable side-effects.

The significant increase shall be established by the manufacturer based on the expected frequency or severity of such incidents in respect of the device.

A manufacturer must document how they manage such incidents and the rationale for the action or inaction they determine to be required.

Competent Authorities

It’s important to note that the Competent Authorities may conduct their own assessments on the trend reports and require the manufacturer to adopt further measures to ensure patient safety and protect public health.

Each competent authority shall inform the Commission, the other competent authorities, and the notified body that issued the certificate, of the results of such assessments.