Manufacturer's incident reporting procedure
The requirements of the incident reporting procedure for medical devices depend on the type of the medical device concerned – medical or IVD medical device – and the regulatory basis on which the device was placed on the market. The incident reporting procedures are described according to the regulatory basis of the device.
Incident reporting procedure according to the MD and IVD Regulation
The incident reporting procedure pursuant to Medical Devices Regulation (EU) 2017/745 (MD Regulation) is applied to medical devices in compliance the Regulation and to devices placed on the market pursuant to Article 120(3) (‘legacy devices’, MDCG 2021-25).
The incident reporting procedure pursuant to In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVD Regulation) is applied to all medical devices in compliance with the Regulation starting from 26 May 2022 and to devices placed on the market pursuant to Article 110(3) (‘legacy devices’, MDCG 2022-8).
The requirements for the incident notification procedure set out in the Regulations differ from those set out in Directives 93/42/EEC and 98/79/EC. Earlier, basically all incidents were reported as isolated events, but in future, serious incidents pertaining to devices in compliance with the Regulations and legacy devices will be reported as individual reports (Articles 87/82), and incidents and expected side effects (medical devices) and expected erroneous results (IVD devices) as trend reports (Articles 88/83).
Adverse incident reporting procedure in accordance with the Directives
Medical devices placed on the market before 26 May 2021
Devices that have been placed on the market before 26 May 2021 are so-called “old devices” for which the incident reporting procedure set out in Medical Devices Directive 93/42/EEC is to be complied with. However, according to the Commission guidelines, manufacturers can also follow the incident reporting procedure in accordance with the MD Regulation with regard to these devices as well.
IVD devices placed on the market before 26 May 2022
IVD medical devices that have been placed on the market before 26 May 2022 are so-called “old devices” for which the incident reporting procedure set out in Medical Devices Directive 98/79/EC is to be complied with. With regard to IVD medical devices, the Act on Certain Medical Devices Specified in EU Directives and Fimea’s Administrative Regulation on the manufacturer’s incident reporting procedure concerning in vitro diagnostic medical devices (4/2022) shall be complied with.