Regulatory Authority Communication SOP

[clarked3]

Hi All,


I work for a Class III Medical Device manufacturer. We recently had a 13485 notified body surveillance audit. We got pulled up for "Change procedure does not cite "NB" form NBXXXX - "Medical Devices Notification of Changes or Regulatory Action."


Whilst we find it a bit odd that we need to site another company's form in our QMS system we are planning to insert the reference.


However, the form asks us to notify NB of changes to:
- The certified name and address
- Name and Email of primary and secondary contact
- Number of employees covered by the scope
- Critical suppliers
- etc.


As these sort of things wouldn't go through change control the trigger to complete the form shouldn't be in the Change Control Procedure.
I have been told other companies have Regulatory Authority Communication SOPs and it would seem like this is the best place to cite the form.


My question is what else is contained in these types of SOPs, i.e. what topics?


At present I am planning to put in Vigilance activities, Audit and Unannounced Audit activities, NB Discussions about individual product lines...


Help?!


Thanks

 

[J0anne]

Oops let me write that again.

 

[J0anne]

Hello Clarked3

Number of employees covered by the scope?
The scope is 13485 and is not limited to numbers of employees and neither is the Directive.

Why are you writing about unannounced audits? Has your NB asked you to do that as well? Yes, you need a procedure in place for unannounced audits, because if they show up unannounced, you will have to deal with it, but you don't have to document it. There is no requirement to document it and the citation is in 93/42/EEC.

As for change, if there is a significant change you would have to notify your NB. However, you can cover this in your risk management file each time you make such a change.


[FONT=&quot]So my best advice to you would be, to ask the NB to direct you to each requirement for everything that?s been requested. Ideally this should be done during the audit or at the closing meeting. But you can still ask. [/FONT]

 

[clarked3]

Taken from the form:


"We are notifying you of the changes detailed below

Change to (Changes can include additions and deletions)

- The certified name and address, other site addresses, activities/scopes/ownership
- Name and email of primary or second contact person
- Number of employees covered by the scope of certification
- Critical suppliers and sub contractors (give name, address, and product/service supplied for new suppliers)
- New or changed OEM?s where you own brand label the devices (give name, address, and devices for any new OEM)
- The structure of the quality Management System or links with related companies
- Major quality system processes or activities
- Major Production, testing or inspection processes
- Sites where unannounced audits might take place ( where final assembly/acceptance testing is undertaken)
- Periods of unavailabilty ( ie when an unannounced audit cannot take place) within the next 12 months
- Medical device product range ie change to generic types manufactured or classifications
- Other (please give details) "

wrt to scope: it refers to the scope of the DE cert.


We currently have an audit/unannounced audit SOP. I want to lump all of this together in a "Regulatory Authority Interaction" SOP rather than write a new SOP. We already have far too many SOPs.


Like the Change Control SOP the Risk Management file/SOP does not capture changes of primary NB contact for example. There doesn't seem to be a logical place to cite this form other than the type of SOP I have mentioned.


The ISO 13485 requirement relating to this citation was "ISO 13485: 2003 Clause 4.2.1 regarding general documentation requirements requires that the quality management system documentation shall include f) any other documentation specified by national or regional regulations." The NB, as per Commission recommendation 2013/473/EU, is required to show compliance to that clause and apparently not citing these change forms shows non compliance.


Personally I feel like they are clutching at straws.

 

[J0anne]

'Any other document specified by national or regional regulations' - in this case this is the MDD that applies to you and not 2013/473/EU which applies to NBs.


The Management Representative already is aware of the NB point of contact for significant changes and this will be included in any agreement and documentation supplied by your NB.

As for you SOP for unannounced audits, every day and every situation is different so I'm not sure why or how you are going to write down what you will do, when you won't know, until it happens; if it happens at all.

My response to NBs about procedures for unannouced audits is that we will deal with it as and if it ever arises. This is discussed at management review meetings and is documented in the minutes, so that everyone is aware of the situation.

I think they are trying to make you jump through hoops.

 

[Sarah Stec]

For the items you mention in your first post, I've seen a lot of companies use the management representative or the main contact person for the NB (like the head of Regulatory or Quality) to be the one responsible for notifying the NB of the changes. In your case, I don't know if it would be a complete SOP or an update of the responsibilities for the position.

I have no comment as to their requirement to adopt their procedures into yours - every NB is a bit different. However, the changes that they ask to be notified about are pretty reasonable, and could affect your certification. For example, a change in name = change in legal manufacturer = who exactly is being certified? Change in # of employees = is the audit duration enough to adequately assess the functioning of the QMS (or is it too long)? Change in main NB contact = who to talk to regarding that outstanding corrective action that is needed to continue the certification process? Sometimes these things really aren't changes that can be absorbed at the time of the audit for various reasons, so the NB needs to know them ahead of time.

 

[Pads38]

Your NB's form is there to guide you as to when any changes you make have to be communicated to your NB.

So in your 'Change Procedure' you will have a Yes/No tick box alongside the question "Does this change need to be reported to our NB? - See NB Form NBXXXX"

As for unannounced audits - they do require a written procedure (source - the chair of the NB-MED co-ordination group). It will lay out responsibilities during an audit and what happens should key staff be off-site when the unannounced audit happens.