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MDR Accessories

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Guest user Created:   Feb 25, 2021 Last commented:   Feb 26, 2021

MDR Accessories

Please could you provide advise on the following situation:

If a part of a medical device is attached to the device, it becomes a component, but if the same part is provided separately to the user in order to fulfil the medical device`s intended purpose, it becomes an accessory. Is that correct?

Considering the scope and requirements of the MDR, the components are a part of the medical device itself which goes through the certification process. If the components are manufactured in bulk, kept in stock, and attached to the final product to fulfil the orders requirements, is it required for them to have the date of manufacture on them, or would the date of manufacture provided on the medical device itself would suffice?

How about the accessories? Do they need to go through the same process as the medical device itself (e.g. have clinical evaluation, technical documentation, DoC, UDI, labelling in compliance with the MDR, PMS, etc.)? If in order to fulfil an order they are supplied separately and additionally to the medical device itself - in a separate bag, would the accessories need to have their CE mark, date of manufacture, and/or serial number on their label in order to be compliant, or is this not a requirement?

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Kristina Zvonar Brkić Feb 26, 2021
1. If a part of a medical device is attached to the device, it becomes a component, but if the same part is provided separately to the user in order to fulfil the medical device`s intended purpose, it becomes an accessory. Is that correct?

Yes, you are correct.   

2. Considering the scope and requirements of the MDR, the components are a part of the medical device itself which goes through the certification process. If the components are manufactured in bulk, kept in stock, and attached to the final product to fulfil the orders requirements, is it required for them to have the date of manufacture on them, or would the date of manufacture provided on the medical device itself would suffice?

The date of the manufacturer is optional and is put on the product only if there is no data for the expiry date. The expiry date of the medical device has to be the one that is shorter. So, if you have components that have an expiry date for example the 02/2022, and the medical device has the expiry date 10/2021, then the final expiry date will be 10/21. To ensure even more traceability, be sure that a lot of the component is visible.

3. How about the accessories? Do they need to go through the same process as the medical device itself (e.g. have clinical evaluation, technical documentation, DoC, UDI, labelling in compliance with the MDR, PMS, etc.)? If in order to fulfil an order they are supplied separately and additionally to the medical device itself - in a separate bag, would the accessories need to have their CE mark, date of manufacture, and/or serial number on their label in order to be compliant, or is this not a requirement?

If your product meets the definition of “accessory for a medical device” given in Article 2(2), then they are subject to all MDR regulatory requirements according to Article 1(1).

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