Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

I recently started in a new position in the orthopedic device space and am new to the field. We have a orthopedic device that is assisted by the use of fixation pins, which we recently started manufacturing and providing (previously, the hospital was required to purchase externally and use). I'm adding the pins to our EC Cert, and was wondering which NBOG medical device code will be applicable - will it be MD 0103 (non-active orthopaedic device) or MD 0106 (non-active instrument). 

My personal interpretation is that it will MD 0106 as it is an accessory for the use of our device and is used only for the duration of the procedure. I would like to hear your expert opinions on this.

Thank you.

Hi,

Have you checked the MDCG guidance for reference?
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_14_mdr_codes_en.pdf

Best regards,
Hannes

------------------------------
Hannes Hyvonen
RA Manager at Icare Finland
Vantaa
Finland
------------------------------

Original Message:
Sent: 13-Apr-2021 18:14
From: Anonymous Member
Subject: NBOG Code application

This message was posted by a user wishing to remain anonymous

Hi All,

I recently started in a new position in the orthopedic device space and am new to the field. We have a orthopedic device that is assisted by the use of fixation pins, which we recently started manufacturing and providing (previously, the hospital was required to purchase externally and use). I'm adding the pins to our EC Cert, and was wondering which NBOG medical device code will be applicable - will it be MD 0103 (non-active orthopaedic device) or MD 0106 (non-active instrument).

My personal interpretation is that it will MD 0106 as it is an accessory for the use of our device and is used only for the duration of the procedure. I would like to hear your expert opinions on this.

Thank you.

This message was posted by a user wishing to remain anonymous

Thank you, Hannes! 

The MDCG guidance was helpful.
Original Message:
Sent: 15-Apr-2021 02:52
From: Hannes Hyvonen
Subject: NBOG Code application

Hi,

Have you checked the MDCG guidance for reference?
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_14_mdr_codes_en.pdf

Best regards,
Hannes

------------------------------
Hannes Hyvonen
RA Manager at Icare Finland
Vantaa
Finland

Original Message:
Sent: 13-Apr-2021 18:14
From: Anonymous Member
Subject: NBOG Code application

This message was posted by a user wishing to remain anonymous

Hi All,

I recently started in a new position in the orthopedic device space and am new to the field. We have a orthopedic device that is assisted by the use of fixation pins, which we recently started manufacturing and providing (previously, the hospital was required to purchase externally and use). I'm adding the pins to our EC Cert, and was wondering which NBOG medical device code will be applicable - will it be MD 0103 (non-active orthopaedic device) or MD 0106 (non-active instrument).

My personal interpretation is that it will MD 0106 as it is an accessory for the use of our device and is used only for the duration of the procedure. I would like to hear your expert opinions on this.

Thank you.