Article 12 Combination Device Registration With Competent Authority

[Bigdubz61]

Can anyone assist with this please. Article 12 states (to the effect of) that when 2 CE marked devices are being packaged together for conjoined use, they do not bear another CE mark on the pack labelling, and that a statement is available that the devices work as intended together. At a recent NB audit, I was advised that items pertaining to Article 12 of the MDD should be registered with the Competent Authority (MHRA). Does anyone have experience of this and how is it done? Thanks in advance.

 

[Ronen E]

It's similar to how class 1 devices are handled. Contact your Authorised Representative.

Other than that, the details are in Article 12:

Article 12

Particular procedure for systems and procedure packs

1. By way of derogation from Article 11 this Article shall apply to systems and procedure packs.

2. Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that:

(a) he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and

(b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and

(c) the whole activity is subjected to appropriate methods of internal control and inspection.

Where the conditions above are not met, as in cases where the system or procedure pack incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to the relevant procedure pursuant to Article 11.

3. Any natural or legal person who sterilized, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilized before use, shall, at his choice, follow one of the procedures referred to in Annex IV, V or VI. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility. The person shall draw up a declaration stating that sterilization has been carried out in accordance with the manufacturer's instructions.

4. The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking. They shall be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the information supplied by the manufacturers of the devices which have been put together. The declaration referred to in paragraphs 2 and 3 above shall be kept at the disposal of competent authorities for a period of five years.

By the way, the relevant term is "a system" or "a procedure pack" and not "a combination device" which is considered a combination of a Medical Devices and a Medicinal Product (a medicine etc.) and is handled differently in the regulatory sense.

 

[Bigdubz61]

Thanks for your response Ronen. It was suggested by our Auditor that there was a form on the MHRA website which could be used. I have looked and can't find it. I have written to MHRA but they will respond in about 18 working days.

Article 12 does not say how to do this.

Is a Declaration of Conformity type document adequate?

 

[Ronen E]

Thanks for your response Ronen. It was suggested by our Auditor that there was a form on the MHRA website which could be used. I have looked and can't find it. I have written to MHRA but they will respond in about 18 working days.

Article 12 does not say how to do this.

Is a Declaration of Conformity type document adequate?

Article 12 prescribes what you need to declare. Formatting is less important. If you'd like that I can prepare such a declaration for you, please send me a PM.

Cheers,
Ronen.

 

[Bigdubz61]

Thanks again Ronen

I will create a DoC type document and send it.