Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

MDR Article 120(3) says: "...the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives..."
What exactly are the requirements that these economic operators need to meet for devices that are being placed on the market under an MDD certificate starting DoA (May 26, 2020)?
Do we have to meet all the requirements of Article 13 (for Importers) and Article 14 (for Distributors) even for devices placed on the market after DoA under an MDD certificate? For example, do Importers need to already indicate their details on these MDD devices? And to perform the required verifications (per Article 13(2)) for MDD devices by DoA?
Or is the requirement for such MDD devices only for the manufacturers to identify the economic operators in internal documentation and "register" them (which we can't really do without EUDAMED, but let's say that until EUDAMED is up and running we would identify the economic operators through appropriate contracts with them + create some sort of internal documentation listing them)?

Thank you,
Anon.

Hello Anon,

This topic has been discussed a few other times on the forums, and again my opinion my differ from others.  The information under Article 120 applies to MDD Certificates to allow those products to continue selling on the market until transition to EU MDR can be made.  I do not believe it has an impact on roles and responsibilities along with other QMS requirements according to the EU MDR post May 2020.  My own opinion is anything dealing with QMS requirements needs to be in place by the compliance date including post market and responsibilities of Economic Operators.  And you are right as activities like registration on EUDAMED is not possible since it does not yet exist.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Mar-2020 20:34
From: Anonymous Member
Subject: Importer and Distributor requirements under MDR Article 120(3)

This message was posted by a user wishing to remain anonymous

MDR Article 120(3) says: "...the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives..."
What exactly are the requirements that these economic operators need to meet for devices that are being placed on the market under an MDD certificate starting DoA (May 26, 2020)?
Do we have to meet all the requirements of Article 13 (for Importers) and Article 14 (for Distributors) even for devices placed on the market after DoA under an MDD certificate? For example, do Importers need to already indicate their details on these MDD devices? And to perform the required verifications (per Article 13(2)) for MDD devices by DoA?
Or is the requirement for such MDD devices only for the manufacturers to identify the economic operators in internal documentation and "register" them (which we can't really do without EUDAMED, but let's say that until EUDAMED is up and running we would identify the economic operators through appropriate contracts with them + create some sort of internal documentation listing them)?

Thank you,
Anon.

Under Article 120(3) the only requirements are those listed. Think of the MDD and the MDR as made of modules. Under Article 120(3) you continue to follow the MDD except you unplug some MDD modules and plug in some MDR modules.

Article 120(3) does say anything about Article 11, Article 13, or Article 14. If the authors of the MDR wanted these modules, they would have said so.

The MDR registration modules are in Article 29 for devices and Article 31 for some economic operators.


Each economic operator register itself; the manufacturer does not register any of the others. This is how the economic operator gets a Single Registration Number, SRN.

When EUDAMED is not fully functional, then Article 123(d)(3) says to revert to the regulation. In this case the module is MDD Article 14, not MDR Article 29 or MDR Article 31.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 22-Mar-2020 20:34
From: Anonymous Member
Subject: Importer and Distributor requirements under MDR Article 120(3)

This message was posted by a user wishing to remain anonymous

MDR Article 120(3) says: "...the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives..."
What exactly are the requirements that these economic operators need to meet for devices that are being placed on the market under an MDD certificate starting DoA (May 26, 2020)?
Do we have to meet all the requirements of Article 13 (for Importers) and Article 14 (for Distributors) even for devices placed on the market after DoA under an MDD certificate? For example, do Importers need to already indicate their details on these MDD devices? And to perform the required verifications (per Article 13(2)) for MDD devices by DoA?
Or is the requirement for such MDD devices only for the manufacturers to identify the economic operators in internal documentation and "register" them (which we can't really do without EUDAMED, but let's say that until EUDAMED is up and running we would identify the economic operators through appropriate contracts with them + create some sort of internal documentation listing them)?

Thank you,
Anon.

This message was posted by a user wishing to remain anonymous

Thank you both for your responses - this is very helpful!
Original Message:
Sent: 24-Mar-2020 08:52
From: Dan O'Leary
Subject: Importer and Distributor requirements under MDR Article 120(3)

Under Article 120(3) the only requirements are those listed. Think of the MDD and the MDR as made of modules. Under Article 120(3) you continue to follow the MDD except you unplug some MDD modules and plug in some MDR modules.

Article 120(3) does say anything about Article 11, Article 13, or Article 14. If the authors of the MDR wanted these modules, they would have said so.

The MDR registration modules are in Article 29 for devices and Article 31 for some economic operators.


Each economic operator register itself; the manufacturer does not register any of the others. This is how the economic operator gets a Single Registration Number, SRN.

When EUDAMED is not fully functional, then Article 123(d)(3) says to revert to the regulation. In this case the module is MDD Article 14, not MDR Article 29 or MDR Article 31.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 22-Mar-2020 20:34
From: Anonymous Member
Subject: Importer and Distributor requirements under MDR Article 120(3)

This message was posted by a user wishing to remain anonymous

MDR Article 120(3) says: "...the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives..."
What exactly are the requirements that these economic operators need to meet for devices that are being placed on the market under an MDD certificate starting DoA (May 26, 2020)?
Do we have to meet all the requirements of Article 13 (for Importers) and Article 14 (for Distributors) even for devices placed on the market after DoA under an MDD certificate? For example, do Importers need to already indicate their details on these MDD devices? And to perform the required verifications (per Article 13(2)) for MDD devices by DoA?
Or is the requirement for such MDD devices only for the manufacturers to identify the economic operators in internal documentation and "register" them (which we can't really do without EUDAMED, but let's say that until EUDAMED is up and running we would identify the economic operators through appropriate contracts with them + create some sort of internal documentation listing them)?

Thank you,
Anon.