Hello Anon,
This goes back to the definitions contained in the EU MDD, EU MDR, and Blue Guide concerning "placing on the market" and "putting into service". Devices such as equipment, instruments, and durable devices (reusable) which are already placed into service, meaning they are at the users and many would say in distributor inventory, are legally now on the market. Even if the Class IIa device does not continue the transition to EU MDR, any devices already put into service can remain as such - these do not have to be withdrawn or taking off the market. Of course, no new devices could be submitted once the EU MDD certificate is cancelled and the Declaration of Conformity is withdrawn. In these instances, there should definitely be an "end of life plan" where the company defines Product 'A' is not transitioning to EU MDR, but would need to be supported for 'x' many of years. Indeed you are correct that activities such as servicing, software updates, replacement parts, maintenance, etc., would need to continue to the "end of life" for the product which could be many years.
The tricky part in this is going to be the consumable products because this may be perceived as continue to sell the product if the instrument or equipment is only a platform where the consumables are the "main" intended use. It should be clear the consumables are used for the instrument/equipment to continue functioning according to its intended use. This is something to carefully review. I am not sure you will find any specific guidance on this topic as the implementing regulations are only adjusting the Regulations themselves. It would be nice to have some guidance or Q&A on these type of topics.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
------------------------------
Original Message:
Sent: 19-Feb-2024 13:47
From: Anonymous Member
Subject: Equipment Servicing under EU MDR
This message was posted by a user wishing to remain anonymous
I recently joined a small company and am working through finalizing the MDR strategy (yes, I know we are behind - I am trying to catch them up). The company makes Class IIa devices that are on the market in the EU under MDD. If we decide not to move forward with some of the devices, what does that practically mean for equipment already at an end user? Does that mean that we can no longer support this equipment as all (provide consumables that are available under MDR, servicing, needed software updates, etc.). I have been searching for guidance and have been unable to find anything for this specific instance.
Thanks in advance!