Hello Anon,
To add a further comment, there are plenty of Directives and Regulations which may apply to medical devices/IVD medical devices and are not specifically reviewed or require notification to their Notified Body when complying or implementing. There has already been some comments about informing the Notified Body, maybe in context of a significant change, but personally I would not view this as a notification to the Notified Body. My reason for this is the electronic IFU regulation does not require specific Notified Body oversight - some could argue it does through the EU MDR/EU IVDR. However, during any re-certification audit or surveillance audit, this is something an auditor can confirm compliance by the organisation. As electronic instructions for use are spoken about in the EU MDR/EU IVDR this can be an area audited when claiming compliance (Annex I - GSPR); just like RoHS, REACH, EMC, etc., as long as the auditor has the qualifications and knowledge to audit those areas. There are different electronic instruction requirements in different countries - these would need to be reviewed for each.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 07-Apr-2023 03:00
From: Hans Strobel
Subject: Introducing electronic IFU's
Hello
Some information upfront: A key question is if you plan eIFU in addition to paper IFU or as a replacement. Assuming it is the second (and assuming that your device is used exclusively by healthcare professionals) you have to set up an eIFU System. All eIFU regulations require the following for such a system:
- a process that allows the intended user to request a paper IFU free of charge
- system risk analysis
- definition of requirements/processes and computer system validation (described e.g. in ISO 13485 and 21 CFR Part 11)
- For the EU a fundamental requirement is that your device is covered by EU Reg 2021/2226 Article 3.
Now to your question: Depending on the situation and answers to the above I propose mentioning your plan to your notified body to get an initial response on the process. If the device is eligible for eIFU according to 2021/2226 Article 3, they will (in our experience) assign a reviewer to audit the eIFU System and confirm that it meets the requirements. For non-EU jurisdictions, such a system audit will be part of a regular QMS review.
Kind regards,
Hans
------------------------------
Hans Strobel
www.dokspot.io
Original Message:
Sent: 06-Apr-2023 00:58
From: Anonymous Member
Subject: Introducing electronic IFU's
This message was posted by a user wishing to remain anonymous
We are a manufacturing Class IIa medical device company and a Class 3 in Canada, distributing products in Europe and MDSAP Countries. We also are looking into distributing in Ukraine and Russia in the near future. Our Quality System is currently in compliance with applicable regulations. For Europe we are in compliance with MDD 93/42/EEC, transition to MDR 2017/745 is in process.
As part of the labelling improvements, we would like to introduce electronic IFU's. We are wondering if we need to notify our NB to review and approval prior to implementation? If yes, what would we need to do? Any guidance would be greatly appreciated