ISO 13485 & EU MDR - Expert Advice Community

MDR Labelling

For a company that manufactures textile medical devices having all the required information but the date of manufacture (the expiration date is not applicable) on a woven label which is directly sewn onto the medical device, is it acceptable under the MDR to have the date of manufacture printed on a sticker label which will be placed on the device`s first level of packaging - plastic bag (every device is packaged individually)?  

Auditing and creating checklist for medical device labeling

How to audit and create a checklist for medical device labeling including advertising and claims?

Most difficult issue and challenge during initial implementation

What would be the most difficult issue and challenge during initial implementation?

PMS process

I am new to the PMS process, we have our procedure and plan in place for a class i medical device. Is this template the report that will be submitted for the audit? or this this report tempate just to be used for PMS reviews?

Also can data be analysed in terms of figures (i,e percentages) or can it be presented in graphical form with appendices?

Necessity of MDD and MDR for contract manufacturing companies

How a repair under the ISO 13485 can be deemed acceptable?

i would like to understand how a repair under the iso 13485 can be deemed acceptable for another manufacturers CE marking when the same processes have not been certified by the OEM company

Critical non-conformities

What can I do if critical nonconformities have been detected and my boss wants to continue the production without taking corrective actions?

MDR classification

I want to ask about MDR classification. As there are two categories for active devices
1. Active therapeutic device
2.Active device intended for diagnosis and monitoring
I get confused which one is close to intensive care ventilators?
and is rule 22 applicable for these devices?

New requirements for technical files

We are working through our documentation with the help of Advisera. I do have questions on the new requirements for technical files. Do you have any samples or templates available?

Coding records

I was hoping to get some more information in regards to the 3.1 Creation and identification of documents section in the Procedure for Document and Record Control. 

There is a bullet that says: 

Records are coded in the following way: [describe the organization’s standard practice].
To the best of my knowledge we have never “coded” any records in any particular way so I’m working on creating the logic for this. 

The paper offers an example of adding a numerical number after the procedure’s document code but I’m not sure what I’m supposed to do with that record code after we’ve assigned it.  

·         Does that code need to be on the record?  

·         If so, how does that work with forms and their code? 

o   For example, say we have a procedure on logging non-conforming material.  The procedure is coded “PR-001”, we have a form the employee needs to fill out coded “PR-001-F”, the employee fills it out and now it’s considered a “record” so what should the record be coded and does that now need to be written on the record itself?

·         Also, how does that code need to appear on things that are run automatically like for example, backup logs?  Do we just add that code to the file name of the backup?

I realize all of this is up to our discretion and I may be WAY overcomplicating this, but I’m drawing a blank on how to set it up.