Regulatory Open Forum

Greetings,

I have a few questions regarding the application of MDR Article 22 Systems and Procedure Packs.

My company provides an accessory kit that contains an SpO2 module, SpO2 sensor, and patient cable. The SpO2 module is CE marked by my company, the SpO2 sensor and patient cable are CE marked by their manufacturer. We combine all three items and provide them in one package. Note, my company includes a quick start guide for the SpO2 module and the manufacturer IFU is included with the SpO2 sensor.

If I understand Article 22 correctly, this meets the definition of a system due to the following conditions:

(1) Every individual medical device placed on the market as part of the system bears the CE marking on the device,
and (2) the individual devices are not put to a different use to that intended by the original manufacturer of the devices.

Please correct me if I'm wrong, but with multiple manufacturers' CE marked devices in one package, the outer packaging should not bear a CE mark since my company is not taking responsibility for all CE marked items in the package.

Additionally, my company has to make a declaration as outlined in Article 22(2). Is that declaration to be included on the parent device's declaration of conformity?

Lastly, I was informed by our notified body that we cannot list 3rd party accessories on our DoC. However, I'm now confused as to how I include this accessory System on any type of declaration since it contains a mixture of CE marked products. Do we include the system on the parent device's DoC? Create a separate DoC for the accessory System and, if so, how would we declare classification, etc.?

Best regards, Tonia

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Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
------------------------------

HI Tonia, article 22 does not require that the article 22 declaration is included in the DoC of any of the devices in the system. The article 22 declaration is a standalone document, see article 22 (5) and is to be kept at the disposal of the authorities. The system is not a device in its own right so it does not get classified (unless it is because one of the devices in it is not CE marked, then it is a device in its own right and does get classified).
Note that you do need to comply with a number of items for the system:
Label the system with system composer details
Annex I.23 information
Registration of the systems composer in Eudamed
Assignment of UDI to the system
Registration of the system

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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 27-May-2022 18:12
From: Tonia E. Bryant
Subject: Application of MDR Article 22

Greetings,

I have a few questions regarding the application of MDR Article 22 Systems and Procedure Packs.

My company provides an accessory kit that contains an SpO2 module, SpO2 sensor, and patient cable. The SpO2 module is CE marked by my company, the SpO2 sensor and patient cable are CE marked by their manufacturer. We combine all three items and provide them in one package. Note, my company includes a quick start guide for the SpO2 module and the manufacturer IFU is included with the SpO2 sensor.

If I understand Article 22 correctly, this meets the definition of a system due to the following conditions:

(1) Every individual medical device placed on the market as part of the system bears the CE marking on the device,
and (2) the individual devices are not put to a different use to that intended by the original manufacturer of the devices.

Please correct me if I'm wrong, but with multiple manufacturers' CE marked devices in one package, the outer packaging should not bear a CE mark since my company is not taking responsibility for all CE marked items in the package.

Additionally, my company has to make a declaration as outlined in Article 22(2). Is that declaration to be included on the parent device's declaration of conformity?

Lastly, I was informed by our notified body that we cannot list 3rd party accessories on our DoC. However, I'm now confused as to how I include this accessory System on any type of declaration since it contains a mixture of CE marked products. Do we include the system on the parent device's DoC? Create a separate DoC for the accessory System and, if so, how would we declare classification, etc.?

Best regards, Tonia

------------------------------
Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
------------------------------