Technical File Updates and Notified Body Notification

D

DesiQE

#1
Hi,

How often do you uprev your technical file?

What sort of changes in design/process/documentation indicate a notification to the NB?

Do you keep track of all the changes done in your change control system to be shown during a surveillance audit?

Guidance would be highly appreciated.
 
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M

MIREGMGR

#2
How often do you uprev your technical file?
Lately, about once a month, which is pretty much a continuous process. We originally expected that the more we learned, the closer to perfect we would get, and thus the longer the interval would become between changes. The opposite has turned out to be the case...the better the company gets at understanding what we're doing and what our customers need, the more often we recognize something that we should improve.

What sort of changes in design/process/documentation indicate a notification to the NB?
I don't think there's a generic answer to this. It depends on your product class(es), certificate scope, and your contract with them.

Do you keep track of all the changes done in your change control system to be shown during a surveillance audit?
We definitely document all changes, but we only discuss with auditors...NB, customer or internal...those changes that we're asked about.
 

somashekar

Staff member
Super Moderator
#3
Hi,

What sort of changes in design/process/documentation indicate a notification to the NB?
.
Your obligation to inform the NB under :
1. Product changes - If the change would effect conformity with the essential requirements and / or the conditions prescribed for the intended use of the device.
a. change introduces a new device or new hazard which has not been previously addressed.
b. change adversly affects the risk associated with existing hazards
c. change alters the details on intended use na d/ or compliance with the essential requirement given in the device master record submitted to the NB.
d. Change means that the device will have different end user or be used in a different manner or for a different purpose.
e. Change means that the clinical data from the original device is not sufficient to confirm conformity of the changed device with the required characteristecs and performance.

2. Changes to Quality system - The matters that are considered when deciding whether or not particular changes are substantial include the following.
a. Change alters the manufacturing technology.
b. Change affects product conformity route.
c. Change affects the continued compliance of the quality system with the relevant harmonized standards against which it has been approved.
d. Change affects the arrangement for ensuring continued compliance with the requirements of the directiv. Ex. verification , validation etc...
e. change require that the manufacturing processes and controls are re-validated.

The above are termed as Substantial changes. Your notification to the NB must include :
1. Brief description of the modifications compared to the approved design / device or the approved quality system.
2. Reason for changes / modifications.
3. In the case of design / device changes, a statement on the relevance to the compliance with the essential requirements of the directive.
 
Y

yana prus

#4
Hi,

What sort of changes in design/process/documentation indicate a notification to the NB?
In addition to the changes mentioned by Somashekar, I would add the Organizational changes:

Organizational changes:

* Change of legal form or name of the company (may affect the CE Certificate)

* Change of company address

* Business units, subsidiaries or manufacturing sites to be added or deleted

* Change of number of employees since the last audit (since the number of the audit days depends on this data)

* Change of personal responsibilities (quality management representative)

Regards,

Yana​
 
Last edited by a moderator:

Peter Selvey

Staff member
Super Moderator
#6
The obligation to report changes to the NB are stated in each MDD Annex and vary depending on the Annex. For example MDD Annex II (full quality system), Section 3.4 states that only changes to the quality system or product range need to be reported.

The list of requirements above, which is derived from the NB-med referred to in the link above are (a) old (b) not law (c) not approved by the EU (d) not practical since NBs don't have the resources to review every change, and (e) rarely followed in practice because it is not practical.

The NBOG series of documents are intended to replace NB-MEDs, and are reviewed and approved by the EU. You will find them to be more carefully worded to reflect the MDD. According to NBOG BPG 2009-4, Section 9 (Changes/New Devices) states that:

Manufacturers introducing a new subcategory of Class IIa device or a new generic Class IIb device need to inform their NB who need to review relevant technical documentation prior to the products being placed on the market. For changes to existing designs the normal change requirements apply.
Of course, this should not be confused with information the NB needs for planning each audit. Prior to each audit the NB should ask you for things like number of employees, list of CE marked device etc etc. These are not for review but for audit planning.
 
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