Hi Kevin,
MDD mentions that "Devices intended to be sterilized must be manufactured in appropriately controlled (e. g. environmental) conditions."
and MDR "Devices intended to be sterilized shall be manufactured and packaged in appropriate and controlled conditions and facilities."
If the devices are intended to be sterilized it is difficult to avoid the cleanroom, because it will be difficult to prove that your facilities are appropriately controlled.
Hope that helps
------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------
Original Message:
Sent: 16-Jun-2020 19:34
From: Kevin Walls
Subject: Respirators Manufactured in a Cleanroom
Do respirators (facemasks) need to be manufactured in a cleanroom?