Regulatory Open Forum

Hi All,

We recently had our Medical Devices Audit. One of the recommendations included notifying the notified body of any changes significant or minimal to the Technical File, so that they can evaluate and decide. 

I was only aware of notifications to the Notified body when the change was significant and had an impact on the design and purpose of use of the device, not for documentation updates such as labelling etc. Since we would like to follow up and submit all these changes. Does anyone know what the steps / process/ specific forms are or how to contact the notified body in order to be compliant with the auditors' observations? 

Thanks, in advance!

Your auditor is wrong, and you should not comply. The auditor offered an opinion whose only effect would be to create non-valued extra work for your company and the NB.

The requirement is in EU-MDR Annex IX 4.10. Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof.

Changes that meet this requirement are covered in the surveillance audits on a sampling basis.

Typically, your contract with the NB will be more specific about when to make this notification. Find the wording and implement it. If it is not covered in the contract, just use the Annex IX wording as the requirement.

Hi All,

We recently had our Medical Devices Audit. One of the recommendations included notifying the notified body of any changes significant or minimal to the Technical File, so that they can evaluate and decide. 

I was only aware of notifications to the Notified body when the change was significant and had an impact on the design and purpose of use of the device, not for documentation updates such as labelling etc. Since we would like to follow up and submit all these changes. Does anyone know what the steps / process/ specific forms are or how to contact the notified body in order to be compliant with the auditors' observations? 

Thanks, in advance!

Europe's Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex VII sec. 4.9) for Notified Bodies (NBs) to require a manufacturer to notify the NB about certain kinds of changes [e.g., QMS, product range, device design (including labeling), intended use or claims, type, and chemical substances) without clear regard to significance so as to enable the NB to assess the impact. Because that includes a concomitant requirement for the NB to have in place corresponding documented procedures and contractual arrangements, you should start by reviewing your NB contract and inquiring of the NB so as to leverage any existing infrastructure already set up by your NB.

Internally, you need to be sure your QMS has corresponding interfaces.  First, in your change management process, where you need to screen changes against the NB's notification requirements.  For those changes that meet the regulator's (e.g., the NB's or other agency's such as Health Canada's) notification thresholds, I have in the past set up a database and form to record such changes in a strategic way for presentation to the regulator for this context.  Then these strategic record(s) of change(s) are submitted to the regulator (e.g., the NB) in accordance with its applicable procedures and timelines that will be in your contract.

We would also need to know more about your "Medical Devices Audit" and to see the exact wording of the recommendation.  Was that an internal audit? An audit by the NB? Other? Those details will also impact your proper response.

Your auditor is wrong, and you should not comply. The auditor offered an opinion whose only effect would be to create non-valued extra work for your company and the NB.

The requirement is in EU-MDR Annex IX 4.10. Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof.

Changes that meet this requirement are covered in the surveillance audits on a sampling basis.

Typically, your contract with the NB will be more specific about when to make this notification. Find the wording and implement it. If it is not covered in the contract, just use the Annex IX wording as the requirement.

Hi All,

We recently had our Medical Devices Audit. One of the recommendations included notifying the notified body of any changes significant or minimal to the Technical File, so that they can evaluate and decide. 

I was only aware of notifications to the Notified body when the change was significant and had an impact on the design and purpose of use of the device, not for documentation updates such as labelling etc. Since we would like to follow up and submit all these changes. Does anyone know what the steps / process/ specific forms are or how to contact the notified body in order to be compliant with the auditors' observations? 

Thanks, in advance!

Hi All,

We recently had our Medical Devices Audit. One of the recommendations included notifying the notified body of any changes significant or minimal to the Technical File, so that they can evaluate and decide. 

I was only aware of notifications to the Notified body when the change was significant and had an impact on the design and purpose of use of the device, not for documentation updates such as labelling etc. Since we would like to follow up and submit all these changes. Does anyone know what the steps / process/ specific forms are or how to contact the notified body in order to be compliant with the auditors' observations? 

Thanks, in advance!