Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Per (EU) 2017/745, Article 18, the information provided in the implant card is for the purposes of making it available to the particular patient who has been implanted with the device, by means that allow rapid access to that information.

Article 120, Transitional provisions, (3) indicate that requirements of the Regulation relating to postmarket surveillance, vigilance, etc. apply as of 26 May 2020.

For implantable products, when must an implant card be included with the product? Upon CE mark of the device under MDR; or, in accordance with Article 120, Transitional provisions, by May 2020? Is the implant card considered to be labeling? If a device that will require an implant card will not transition until May 2024, how will implementation of the card be reviewed by the NB before that time?

This is a bit tricky because while expectation for any quality system process must be implemented by 26 May 2020 there are some product specific items staying with a MDD Certificate if this is extended beyond May 2020, i.e. a CE Cert with an expiration date of 2023 or 2024 under Article 120.  Unfortunately there is no line-by-line listing of what articles or requirements must be applied post May 2020 and those that stay with the products MDD CE Certificate.  However, it is understood fairly much only Technical Documentation, Essential Requirements, Clinical Evaluation, Declaration of Conformity, i.e. all of those documents related to the "old" Technical File would remain under the MDD.  Then everything else should technically transition to EU MDR.  My own opinion is you should be preparing for implant cards to be sent out before and definitely after the 26th May.  Remember the EU MDR is currently "in force" so while there are only a few Notified Bodies designated, compliance with EU MDR can be done now.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Oct-2019 11:46
From: Anonymous Member
Subject: Implant Card

This message was posted by a user wishing to remain anonymous

Per (EU) 2017/745, Article 18, the information provided in the implant card is for the purposes of making it available to the particular patient who has been implanted with the device, by means that allow rapid access to that information.

Article 120, Transitional provisions, (3) indicate that requirements of the Regulation relating to postmarket surveillance, vigilance, etc. apply as of 26 May 2020.

For implantable products, when must an implant card be included with the product? Upon CE mark of the device under MDR; or, in accordance with Article 120, Transitional provisions, by May 2020? Is the implant card considered to be labeling? If a device that will require an implant card will not transition until May 2024, how will implementation of the card be reviewed by the NB before that time?

A device/QMS can be in one of three states: MDD only, Article 120, or MDR only. Article 120(3) has a specific list of requirements for the QMS and their application to the device. An Article 120 device does not need an implant card, since it is not on the list.

 

You must include the implant plant when your device/QMS becomes MDR only. You may implement it sooner. When you apply to the MDR NB, typically under Annex IX, the NB will expect to see you plans for the implant card. If not satisfactory, you will not get a certificate.

 

Remember that the Article 120 transition ends on the expiration date of the MDD device certificate or in May 2024, which ever comes sooner.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 10-Oct-2019 11:46
From: Anonymous Member
Subject: Implant Card

This message was posted by a user wishing to remain anonymous

Per (EU) 2017/745, Article 18, the information provided in the implant card is for the purposes of making it available to the particular patient who has been implanted with the device, by means that allow rapid access to that information.

Article 120, Transitional provisions, (3) indicate that requirements of the Regulation relating to postmarket surveillance, vigilance, etc. apply as of 26 May 2020.

For implantable products, when must an implant card be included with the product? Upon CE mark of the device under MDR; or, in accordance with Article 120, Transitional provisions, by May 2020? Is the implant card considered to be labeling? If a device that will require an implant card will not transition until May 2024, how will implementation of the card be reviewed by the NB before that time?

I agree with Dan based on the wording in Article 120(3) stating that it is with a valid MDD / AIMD certificate that a device can continue to be placed on the market "provided that it continues to comply with either of those directives​. . . "  I believe this includes the labeling requirements of those directives since the following sentence states that the requirements of PMS, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those directives.  It doesn't say that any of the labeling requirements are to be replaced by the labeling requirements of the MDR.

Amy

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Amy McKinney RAC
Sr Manager, Regulatory Affairs, Interventional Oncology
Fulshear TX
United States
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Original Message:
Sent: 10-Oct-2019 11:46
From: Anonymous Member
Subject: Implant Card

This message was posted by a user wishing to remain anonymous

Per (EU) 2017/745, Article 18, the information provided in the implant card is for the purposes of making it available to the particular patient who has been implanted with the device, by means that allow rapid access to that information.

Article 120, Transitional provisions, (3) indicate that requirements of the Regulation relating to postmarket surveillance, vigilance, etc. apply as of 26 May 2020.

For implantable products, when must an implant card be included with the product? Upon CE mark of the device under MDR; or, in accordance with Article 120, Transitional provisions, by May 2020? Is the implant card considered to be labeling? If a device that will require an implant card will not transition until May 2024, how will implementation of the card be reviewed by the NB before that time?

Thank you, Amy, Dan and Richard for your replies.

I understand each perspective.  However, I tend to agree with Dan and Amy for all the reason stated.

Article 120(3) stating that it is with a valid MDD / AIMD certificate that a device can continue to be placed on the market "provided that it continues to comply with either of those directives​. . . "   does include the labeling requirements as the only explicit  association of the requirements for Article 18, Implant cards, is with Annex I, Chapter III - Requirements Regarding Information Supplied with the Device, 4 (aa).  Neither Article 18, nor implant cards is associated/mentioned in the Article 120, Transitional provisions.

The purpose  of the implant card  is to make  information available to the particular patient who has been implanted with the device. This purpose does not necessarily support an association with postmarket surveillance, vigilance, etc.

We will inquire with our NB about implementing an implant card sooner than later. If it is considered to be a significant change to our devices (as I anticipate that I might be), it will wait until our planned transition.

Thank you.

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Melissa M. Traylor
Regulatory Affairs
FzioMed, Inc.
San Luis Obispo, California
USA
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Original Message:
Sent: 14-Oct-2019 11:57
From: Amy McKinney
Subject: Implant Card

I agree with Dan based on the wording in Article 120(3) stating that it is with a valid MDD / AIMD certificate that a device can continue to be placed on the market "provided that it continues to comply with either of those directives​. . . "  I believe this includes the labeling requirements of those directives since the following sentence states that the requirements of PMS, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those directives.  It doesn't say that any of the labeling requirements are to be replaced by the labeling requirements of the MDR.

Amy

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Amy McKinney RAC
Sr Manager, Regulatory Affairs, Interventional Oncology
Fulshear TX
United States

Original Message:
Sent: 10-Oct-2019 11:46
From: Anonymous Member
Subject: Implant Card

This message was posted by a user wishing to remain anonymous

Per (EU) 2017/745, Article 18, the information provided in the implant card is for the purposes of making it available to the particular patient who has been implanted with the device, by means that allow rapid access to that information.

Article 120, Transitional provisions, (3) indicate that requirements of the Regulation relating to postmarket surveillance, vigilance, etc. apply as of 26 May 2020.

For implantable products, when must an implant card be included with the product? Upon CE mark of the device under MDR; or, in accordance with Article 120, Transitional provisions, by May 2020? Is the implant card considered to be labeling? If a device that will require an implant card will not transition until May 2024, how will implementation of the card be reviewed by the NB before that time?

This message was posted by a user wishing to remain anonymous

Hello

Another question on Implant cards, per MDR, article 18 (a), the device name is one of the minimum elements that shall be in the IC, however some devices have too long names to be added in a reduced space within the implant card. Would it be allowed to make devices names shorter to include them in implant cards? Or should they be provided as longer as they are?

Could someone advice on this?
Original Message:
Sent: 10-Oct-2019 11:46
From: Anonymous Member
Subject: Implant Card

This message was posted by a user wishing to remain anonymous

Per (EU) 2017/745, Article 18, the information provided in the implant card is for the purposes of making it available to the particular patient who has been implanted with the device, by means that allow rapid access to that information.

Article 120, Transitional provisions, (3) indicate that requirements of the Regulation relating to postmarket surveillance, vigilance, etc. apply as of 26 May 2020.

For implantable products, when must an implant card be included with the product? Upon CE mark of the device under MDR; or, in accordance with Article 120, Transitional provisions, by May 2020? Is the implant card considered to be labeling? If a device that will require an implant card will not transition until May 2024, how will implementation of the card be reviewed by the NB before that time?