You are correct that the Class I medical device can be packaged and sold as a stand-alone product or together with a Class IIa/IIb device without taking on the higher classification. In fact, this is more clear now in the Medical Device Regulation 2017/745 EU that an accessory or connected device can have its own classification without automatically taking on the classification of the parent device, even if a higher classification. You will of course want to make sure there is technical documentation, DofC, labelling, etc. for the Class I product.
You raised a million dollar questions concerning spare parts - congratulations ! Just kidding. Though without kidding this is a poorly described aspect in any regulation regard spare parts. Accessories, connected device, interconnectivity of devices, etc. have been clarified a bit in the MDR and other regulatory agencies have provided guidance documents on accessories, what is an accessory, how they should be regulated. However, what is still not clearly addressed is how spare parts should handled. Let me give you my own personal opinion - this is my own thoughts and views, so other may have different views which would also be interesting to read.
Spare parts are "part" of the device, therefore when there are spare parts provided they would be the classification of the device. Think of it in a way that the spare parts are not medical devices on their own, could not be medical devices on their own, and theoretically the medical device can not function on its own with the spare parts. There is note much in the regulation about spare parts, so quite some interpretation has to be made. My thoughts are that spare parts using Good Manufacturing Practices (GMP) would apply to how these would be identified, labeled, and indicated. So your thoughts are what I would suggest is the spare parts have all the necessary content on labels such as part number, lot number/serial number, expiration dates, storage conditions, etc., anything that would be applicable and what I have done in the past is clearly state that Part Number 1234 is only to be used with Product X, Model Number 789 on the label. An IFU is not needed, but the label does have that note. Also often times it is a FSE or other internal/external contract engineer that may be repairing the device, so labelling is still important, and maybe a service manual is also connected to the spare parts and how they are replaced.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 08-Jun-2018 05:35
From: Anonymous Member
Subject: Labelling spare parts & their packaging (EU)
This message was posted by a user wishing to remain anonymous
We are developing a class II device with several spare parts and I am getting confused on the labelling required for each and their packaging.
The following parts shall be boxed & included within the main device packaging (box within a box) or sending out as spares.
- off-the-shelf class I medical devices - already supplied boxed & labelled,
- spare part of class II device (regularly user replaceable part)
It will be sold in Europe, so I believe the (boxed) class I devices can be supplied with the main class II device and not inherit it's classification i.e. boxes within boxes. If they were sold in the US for example, they would however inherit the parent device classification.
The spare part for the main class II device is what confuses me, I think it should include the following:
- Name of main device
- REF (to part number)
- Lot number (will be batch production)
- Date of manufacture
- Applied part symbol
- Other symbols included on label for main class II device not required (e.g. CE, read the manual)
Should the packaging also include the same info and also symbols for the storage environment?