Regulatory Open Forum

Hello, 

we are preparing for our first Technical Documentation submission for our class IIa device for CE Mark under the EU MDR. Previously, we were not considered medical under the MDD, so this is our very first foray into the world of NB review of our Technical Documentation. Many of our reports have been electronically signed and are therefore validated and encrypted (PDFs) and cannot be modified after the fact. In the guidance that our NB sent regarding how they want the documents presented, they have said:

"All technical documentation submitted cannot be locked or encrypted, otherwise it will be an issue for review purposes. Please make sure that the product assessor /reviewer is allowed to copy text and images from the files."

Does anyone have any experience with this and a way to be able to copy text out of an encrypted PDF?

I did reach out to my NB Account Rep and asked for clarification, and they just copied and pasted the above text, which is verbatim from the guidance they previously provided. 

thanks everyone!

I have provided unofficial unsigned copies (so marked) for content review along with the signed encrypted copy either immediately/proactively or later upon request.

Hello, 

we are preparing for our first Technical Documentation submission for our class IIa device for CE Mark under the EU MDR. Previously, we were not considered medical under the MDD, so this is our very first foray into the world of NB review of our Technical Documentation. Many of our reports have been electronically signed and are therefore validated and encrypted (PDFs) and cannot be modified after the fact. In the guidance that our NB sent regarding how they want the documents presented, they have said:

"All technical documentation submitted cannot be locked or encrypted, otherwise it will be an issue for review purposes. Please make sure that the product assessor /reviewer is allowed to copy text and images from the files."

Does anyone have any experience with this and a way to be able to copy text out of an encrypted PDF?

I did reach out to my NB Account Rep and asked for clarification, and they just copied and pasted the above text, which is verbatim from the guidance they previously provided. 

thanks everyone!

Hello, 

we are preparing for our first Technical Documentation submission for our class IIa device for CE Mark under the EU MDR. Previously, we were not considered medical under the MDD, so this is our very first foray into the world of NB review of our Technical Documentation. Many of our reports have been electronically signed and are therefore validated and encrypted (PDFs) and cannot be modified after the fact. In the guidance that our NB sent regarding how they want the documents presented, they have said:

"All technical documentation submitted cannot be locked or encrypted, otherwise it will be an issue for review purposes. Please make sure that the product assessor /reviewer is allowed to copy text and images from the files."

Does anyone have any experience with this and a way to be able to copy text out of an encrypted PDF?

I did reach out to my NB Account Rep and asked for clarification, and they just copied and pasted the above text, which is verbatim from the guidance they previously provided. 

thanks everyone!