Cleanroom for medical devices

27/03/2025, 11:30 · Room 7 · DE

Medical device manufacturing and cleanrooms very often go hand in hand. What constitutes a medical device and an in vitro diagnostic medical device is precisely defined in the two EU regulations. After a transitional period, the Medical Devices Act was replaced by the Medical Devices Regulation in May 2021 and the In Vitro Diagnostic Medical Devices Regulation in May 2022. What has changed for the installers of cleanroom systems? What are the requirements for setting up a cleanroom and what requirements must the cleanroom fulfil? How is the cleanroom system qualified and what specifications are required by the customer?

Agenda

Medical Device Regulation MDR
In Vitro Diagnostics Regulation IVDR
Cleanrooms for the production of medical devices
Risk assessment, scope of qualification and effort