Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Does anyone know the regulations for not putting IFUs on devices and only having them electronically available for customers, or where I could find this type of information?

Hello

Below is a list of regulations for (or related to) eIFU.

Consider, that besides the regulatory requirements, quality assurance processes such as computer system validation are required. 
  

Australia	Electronic Instructions for Use - eIFU
Brasil	Normative Instruction-IN N°4, OF June 15th, 2012
European Union	Commission Regulation 207/2012
Turkey	TIBBİ CİHAZLARIN ELEKTRONİK KULLANIM TALİMATLARI HAKKINDA TEBLİĞ BİRİNCİ BÖLÜM
Saudi Arabia	GUIDANCE O LABELLING REQUIREMENTS FOR MEDICAL DEVICES
USA	FDA Blue Book Memorandum on electronic instructions for use Medical Device User Fee and Modernization Act of 2002 - see Section 206
India	MTAL - Acceptance of eIFU for Medical Device a Welcome Move: MTa
Canada	Guidance Document: Guidance for the Labelling of Medical Devices

------------------------------
Hans Strobel
www.dokspot.io
------------------------------

Original Message:
Sent: 02-Nov-2021 14:39
From: Anonymous Member
Subject: Electronic IFU's

This message was posted by a user wishing to remain anonymous

Does anyone know the regulations for not putting IFUs on devices and only having them electronically available for customers, or where I could find this type of information?

Dear Hans,

thanks for the nice overview.

Best, Dirk

------------------------------
Dirk Steinhoff PhD
Senior Consultant
Zug
Switzerland
------------------------------

Original Message:
Sent: 03-Nov-2021 02:50
From: Hans Strobel
Subject: Electronic IFU's

Hello

Below is a list of regulations for (or related to) eIFU.

Consider, that besides the regulatory requirements, quality assurance processes such as computer system validation are required.
  

Australia	Electronic Instructions for Use - eIFU
Brasil	Normative Instruction-IN N°4, OF June 15th, 2012
European Union	Commission Regulation 207/2012
Turkey	TIBBİ CİHAZLARIN ELEKTRONİK KULLANIM TALİMATLARI HAKKINDA TEBLİĞ BİRİNCİ BÖLÜM
Saudi Arabia	GUIDANCE O LABELLING REQUIREMENTS FOR MEDICAL DEVICES
USA	FDA Blue Book Memorandum on electronic instructions for use Medical Device User Fee and Modernization Act of 2002 - see Section 206
India	MTAL - Acceptance of eIFU for Medical Device a Welcome Move: MTa
Canada	Guidance Document: Guidance for the Labelling of Medical Devices

------------------------------
Hans Strobel
www.dokspot.io

Original Message:
Sent: 02-Nov-2021 14:39
From: Anonymous Member
Subject: Electronic IFU's

This message was posted by a user wishing to remain anonymous

Does anyone know the regulations for not putting IFUs on devices and only having them electronically available for customers, or where I could find this type of information?

Thank you for overview!

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 03-Nov-2021 02:50
From: Hans Strobel
Subject: Electronic IFU's

Hello

Below is a list of regulations for (or related to) eIFU.

Consider, that besides the regulatory requirements, quality assurance processes such as computer system validation are required.
  

Australia	Electronic Instructions for Use - eIFU
Brasil	Normative Instruction-IN N°4, OF June 15th, 2012
European Union	Commission Regulation 207/2012
Turkey	TIBBİ CİHAZLARIN ELEKTRONİK KULLANIM TALİMATLARI HAKKINDA TEBLİĞ BİRİNCİ BÖLÜM
Saudi Arabia	GUIDANCE O LABELLING REQUIREMENTS FOR MEDICAL DEVICES
USA	FDA Blue Book Memorandum on electronic instructions for use Medical Device User Fee and Modernization Act of 2002 - see Section 206
India	MTAL - Acceptance of eIFU for Medical Device a Welcome Move: MTa
Canada	Guidance Document: Guidance for the Labelling of Medical Devices

------------------------------
Hans Strobel
www.dokspot.io

Original Message:
Sent: 02-Nov-2021 14:39
From: Anonymous Member
Subject: Electronic IFU's

This message was posted by a user wishing to remain anonymous

Does anyone know the regulations for not putting IFUs on devices and only having them electronically available for customers, or where I could find this type of information?

Hey Anon
That would be COMMISSION REGULATION (EU) No 207/2012 for Europe.
I think FDA has also requirements on this in the CFR.
There are several threads about this issues lately- I suggest performing a quick search :)
Great day
Ella

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Original Message:
Sent: 02-Nov-2021 14:39
From: Anonymous Member
Subject: Electronic IFU's

This message was posted by a user wishing to remain anonymous

Does anyone know the regulations for not putting IFUs on devices and only having them electronically available for customers, or where I could find this type of information?

Hello Forum,

Does anyone have an English translation of the Japan e-IFU requirements?

Cordially,
Ian

------------------------------
Ian Broome, M.S., RAC
Needham, MA
United States
***Any posts or activity shared on RAPS Forums are my own personal views; I do not speak on behalf of Boston Scientific Corporation (BSC).***
------------------------------

Original Message:
Sent: 03-Nov-2021 02:52
From: Ella Sheiman
Subject: Electronic IFU's

Hey Anon
That would be COMMISSION REGULATION (EU) No 207/2012 for Europe.
I think FDA has also requirements on this in the CFR.
There are several threads about this issues lately- I suggest performing a quick search :)
Great day
Ella

------------------------------
Ella Sheiman
Haifa
Israel

Original Message:
Sent: 02-Nov-2021 14:39
From: Anonymous Member
Subject: Electronic IFU's

This message was posted by a user wishing to remain anonymous

Does anyone know the regulations for not putting IFUs on devices and only having them electronically available for customers, or where I could find this type of information?