Regulatory Open Forum

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Article 120(3) adds additional conditions for a device with an MDD Article 120(2) certificate after the MDR date of application.

Now, apply the chain of reasoning to a Class I reusable surgical instrument. It cannot have an Article 120(2) MDD certificate because the MDD has no such provision. An MDD NB cannot issue such a certificate.

Consequently, the Class I reusable surgical instrument manufacturer cannot use the Article 120 soft transition.

I recommend that these manufacturers notify their customer of a potential shortage and allow the customers to build inventory until the manufacturer can apply an MDR CE Mark.

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Article 120(3) adds additional conditions for a device with an MDD Article 120(2) certificate after the MDR date of application.

Now, apply the chain of reasoning to a Class I reusable surgical instrument. It cannot have an Article 120(2) MDD certificate because the MDD has no such provision. An MDD NB cannot issue such a certificate.

Consequently, the Class I reusable surgical instrument manufacturer cannot use the Article 120 soft transition.

I recommend that these manufacturers notify their customer of a potential shortage and allow the customers to build inventory until the manufacturer can apply an MDR CE Mark.

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

The answer to the transition question is easy. Nobody expected to need it. The plan was that the EU would set up all the machinery in time to designate notified bodies. In parallel, manufacturers would be working on the implementation. It would all come together by May 26, 2020. The back-up plan in Article 120 would be unnecessary.

Things could still work out. Manufacturers of Class I reusable surgical instruments should have all the work completed for full compliance to the MDR. When the manufacturer's NB is designated they could do the audit, issue the MDR certificates, and there would be no disruption.

I think this is an unintended consequence of the need for the Article 120 transition.

Article 120(3) adds additional conditions for a device with an MDD Article 120(2) certificate after the MDR date of application.

Now, apply the chain of reasoning to a Class I reusable surgical instrument. It cannot have an Article 120(2) MDD certificate because the MDD has no such provision. An MDD NB cannot issue such a certificate.

Consequently, the Class I reusable surgical instrument manufacturer cannot use the Article 120 soft transition.

I recommend that these manufacturers notify their customer of a potential shortage and allow the customers to build inventory until the manufacturer can apply an MDR CE Mark.

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Article 120(3) adds additional conditions for a device with an MDD Article 120(2) certificate after the MDR date of application.

Now, apply the chain of reasoning to a Class I reusable surgical instrument. It cannot have an Article 120(2) MDD certificate because the MDD has no such provision. An MDD NB cannot issue such a certificate.

Consequently, the Class I reusable surgical instrument manufacturer cannot use the Article 120 soft transition.

I recommend that these manufacturers notify their customer of a potential shortage and allow the customers to build inventory until the manufacturer can apply an MDR CE Mark.

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Article 120(3) adds additional conditions for a device with an MDD Article 120(2) certificate after the MDR date of application.

Now, apply the chain of reasoning to a Class I reusable surgical instrument. It cannot have an Article 120(2) MDD certificate because the MDD has no such provision. An MDD NB cannot issue such a certificate.

Consequently, the Class I reusable surgical instrument manufacturer cannot use the Article 120 soft transition.

I recommend that these manufacturers notify their customer of a potential shortage and allow the customers to build inventory until the manufacturer can apply an MDR CE Mark.

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

The Article 120 soft transition depends on a valid NB certificate for the device. Article 120(2) second paragraph says that all of these certificates become void on May 27, 2024. Article 120(4) currently says that the soft transition devices may be made available on the market or put into service until May 27, 2025. This is at least one year after the certificate is void. There is an inconsistency here, so I infer that 2025 is a typo and should have been 2024.

This inferred typo would not have changed in the various translations. I expect the next correction document will fix it.

Article 120(3) adds additional conditions for a device with an MDD Article 120(2) certificate after the MDR date of application.

Now, apply the chain of reasoning to a Class I reusable surgical instrument. It cannot have an Article 120(2) MDD certificate because the MDD has no such provision. An MDD NB cannot issue such a certificate.

Consequently, the Class I reusable surgical instrument manufacturer cannot use the Article 120 soft transition.

I recommend that these manufacturers notify their customer of a potential shortage and allow the customers to build inventory until the manufacturer can apply an MDR CE Mark.

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).

Article 120(3) adds additional conditions for a device with an MDD Article 120(2) certificate after the MDR date of application.

Now, apply the chain of reasoning to a Class I reusable surgical instrument. It cannot have an Article 120(2) MDD certificate because the MDD has no such provision. An MDD NB cannot issue such a certificate.

Consequently, the Class I reusable surgical instrument manufacturer cannot use the Article 120 soft transition.

I recommend that these manufacturers notify their customer of a potential shortage and allow the customers to build inventory until the manufacturer can apply an MDR CE Mark.

Be careful about saying Class Ir. There are only four classes, I, IIa, IIb, and III. When you follow the classification rules in Annex VIII, the conclusion will be only one of the classes.

In additional to classes, devices can have attributes such as a reusable surgical instrument. Often the attributes create additional requirements.

Article 52(7), says, "If [Class I] devices are placed on the market in sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." These annexes require an application to a Notified Body, NB. See, for example, Annex IX(2.1).

Article 52(7)(c) limits the NBs involvement for reusable surgical instruments to, "to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use".

Because you don't have an NB certificate under the MDD, you cannot apply the Article 120 soft transition.

The conclusion is that you need an EU-MDR NB certificate to place these devices on the market after May 26, 2020. This is the date of application from Article 123(2).