Regulatory Open Forum

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Based on the information you provided, the audit nonconformance is correct.

The Annex I requirement is to provide certain information on the manufacturer's web site.

In your QMS you declare that the information is available in the IFU only.

Therefore, you must post the IFU on your website.

However, since this is an electronic IFU it must satisfy the 207/2012 requirements.

The solution (to quote a colleague of mine) is obvious to the most casual observer. Change your QMS requirement to allow the information on your web site but not in the IFU.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Based on the information you provided, the audit nonconformance is correct.

The Annex I requirement is to provide certain information on the manufacturer's web site.

In your QMS you declare that the information is available in the IFU only.

Therefore, you must post the IFU on your website.

However, since this is an electronic IFU it must satisfy the 207/2012 requirements.

The solution (to quote a colleague of mine) is obvious to the most casual observer. Change your QMS requirement to allow the information on your web site but not in the IFU.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Based on the information you provided, the audit nonconformance is correct.

The Annex I requirement is to provide certain information on the manufacturer's web site.

In your QMS you declare that the information is available in the IFU only.

Therefore, you must post the IFU on your website.

However, since this is an electronic IFU it must satisfy the 207/2012 requirements.

The solution (to quote a colleague of mine) is obvious to the most casual observer. Change your QMS requirement to allow the information on your web site but not in the IFU.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.

ComplianceAcuity has available a portfolio of topically-arranged EU MDR gap and conformity assessment tools.  Those tools include a decision tree (see attached) reflecting our understanding of the synergy between Regulation (EU) No 207/2012 (hereinafter "the eIFU Regulation") and the EU MDR.  In a nutshell, I generally agree with Peter as illustrated in the attached decision tree.

Here are some key points to consider regarding this topic:

• The information needed to identify the device and its manufacturer, and any safety and performance information relevant to the user or other person [see GSPR 23.1] are merely part of the larger array of elements required in the IFU by GSPR 23.4.  Accordingly, GSPR 23.1 should not be interpreted to mandate placement of the full IFU on the manufacturer's website. Yet, in alignment with the heightened public health initiatives of the EU MDR, it does mandate that the aforesaid subset of IFU information be placed on the website if the manufacturer has a website.
• This new mandate can lead to tension and confusion given that the EU MDR, by way of GSPR 23.1(f), also integrates the longstanding eIFU Regulation and reminds us that the IFU may (not shall) be provided to the user in non-paper format (e.g. electronic format such as a website).  And in such an event, then it must be done in accordance with the boundaries and intent of the eIFU regulation (or any subsequent implementing rules adopted pursuant to the EU MDR). Accordingly, regardless of GSPR 23.1's new mandate, the EU MDR at this time is not meant to undo or alter the intrinsic scope and intent of the eIFU Regulation.
• To review the essence of the eIFU Regulation:
  • Dissemination of eIFU instead of paper IFU is voluntary; is generally restricted to devices that are implantables, active implantables, "fixed installed", fitted with a built-in system visually displaying the IFU, or stand-alone software; and is subject to the applicable conditions of the eIFU Regulation.
  • Alternatively, eIFU may for any device type be provided in addition to paper IFU subject to the applicable conditions of the eIFU Regulation.
• Corresponding checklist items for these competing provisions of the EU MDR and eIFU Regulation are part of ComplianceAcuity's EU MDR topical gap assessment tool for Information Supplied with the Device, which integrates the principles of the attached decision tree illustrating the synergy between Regulations 207/2012 and 2017/745.
• The attached decision tree is aimed at clarifying the relationships between the eIFU Regulation and the EU MDR while spelling out corresponding implementation tactics for various scenarios.

Hope this helps.

Within the new EU Medical Device Regulations (EU) 2017/745, General Safety and Performance Requirement (GSPR) 23.1 states the following:

"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.." [emphasis added]

Should this requirement be interpreted to mean that the IFU must be available on the manufacturer's website (if they have one), or is this still optional? If so, it would also now become obligatory to comply with Regulation (EU) No 207/2012 on electronic labeling (Article 9 in particular)?

Does the MDR essentially mandate supply of electronic IFUs, even when paper copies are provided, just because a manufacturer has a website, which majority of the manufacturers do?

Thank you.