Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear experts, 

I hope you can help me with the doubt I have as it is decisive to define the regulatory pathway to follow.

Our medical device is composed by an intravaginal probe classified as class IIa according to the rule 10 from annex VIII MDR and a web app considered class IIa according to the rule 11. Each product has its intended use but they work together. We know that they will have to have a technical file each and that the evaluation will have to be done separately, but we would like to know if it is possible to present both products in a single certification to the Notified Body or if it is compulsory to certify each of them indepently. 

Thank you

Dear Anon - 

I think one of the critical distinctions to consider is whether they *only* work together and are only distributed 'together'.  Does the web app also function independent of the probe or with other products / probes?  Think ahead to the business plans as well - 

Finally, considering the above, engage with your notified body prior to submitting your technical documentation to see what is preferred or allowed.

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Scott Bishop
McKinney TX
United States
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Original Message:
Sent: 15-Sep-2022 02:30
From: Anonymous Member
Subject: CE MARK CLASS IIa MEDICAL DEVICES

This message was posted by a user wishing to remain anonymous

Dear experts,

I hope you can help me with the doubt I have as it is decisive to define the regulatory pathway to follow.

Our medical device is composed by an intravaginal probe classified as class IIa according to the rule 10 from annex VIII MDR and a web app considered class IIa according to the rule 11. Each product has its intended use but they work together. We know that they will have to have a technical file each and that the evaluation will have to be done separately, but we would like to know if it is possible to present both products in a single certification to the Notified Body or if it is compulsory to certify each of them indepently.

Thank you

It depends. If there is an overarching intended purpose (not the same as intended use of each individual device) then the combination can be CE marked as a single device (article 22 MDR on systems also provides that a system of devices can be CE marked as a single device). In that case you build a single set of technical documentation for the combined products. It is certainly not compulsory to certify each independently - it all depends on how you present what the device subject to certification is.
But, as Scott Bishop said, there may be notified body and commercial considerations that affect the decision whether to bundle it into one device for regulatory purposes or not.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 15-Sep-2022 02:30
From: Anonymous Member
Subject: CE MARK CLASS IIa MEDICAL DEVICES

This message was posted by a user wishing to remain anonymous

Dear experts,

I hope you can help me with the doubt I have as it is decisive to define the regulatory pathway to follow.

Our medical device is composed by an intravaginal probe classified as class IIa according to the rule 10 from annex VIII MDR and a web app considered class IIa according to the rule 11. Each product has its intended use but they work together. We know that they will have to have a technical file each and that the evaluation will have to be done separately, but we would like to know if it is possible to present both products in a single certification to the Notified Body or if it is compulsory to certify each of them indepently.

Thank you