Regulatory Open Forum

First, it is important to note that IM, IS, and IR are not, despite the common usage, classes under the MDR. I have had clients confused by the application of the classification rules in Annex VIII, since they expected a classification of Class IR, say.

The R, S, or M is a requirement of conformity assessment, not of the device class.  For example, there are additional conformity assessment requirements for a Class IIb active device intended to administer and/or remove a medicinal product. We could call them Class IIbM devices.

The point is that the conformity assessment requirements for Class I reusable surgical instruments is in Article 52(7), which requires that the manufacturer apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

Article 52(7.c) says, "However, the involvement of the notified body in those procedures shall be limited, in the case of reusable surgical instruments, 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."

You will need to follow the relevant conformity assessment annex which requires a notified body with limited involvement. The second part, NB, is the source of the problem. Without NB involvement, you will not be able to put the CE Mark on the devices, so, after May 26, 2020 you would not be able place new devices on the EU market.

The Article 120 soft transition would not apply because it requires NB certificates, but you don't have them.

The only hope is that your NB becomes notified under the EU-MDR and has the correct scope for this work.

Products under the MDD are not affected up to May 26, 2020. I recommend you inform your customers of the potential problem so they can build inventory in the event of a shortage.

First, it is important to note that IM, IS, and IR are not, despite the common usage, classes under the MDR. I have had clients confused by the application of the classification rules in Annex VIII, since they expected a classification of Class IR, say.

The R, S, or M is a requirement of conformity assessment, not of the device class.  For example, there are additional conformity assessment requirements for a Class IIb active device intended to administer and/or remove a medicinal product. We could call them Class IIbM devices.

The point is that the conformity assessment requirements for Class I reusable surgical instruments is in Article 52(7), which requires that the manufacturer apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

Article 52(7.c) says, "However, the involvement of the notified body in those procedures shall be limited, in the case of reusable surgical instruments, 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."

You will need to follow the relevant conformity assessment annex which requires a notified body with limited involvement. The second part, NB, is the source of the problem. Without NB involvement, you will not be able to put the CE Mark on the devices, so, after May 26, 2020 you would not be able place new devices on the EU market.

The Article 120 soft transition would not apply because it requires NB certificates, but you don't have them.

The only hope is that your NB becomes notified under the EU-MDR and has the correct scope for this work.

Products under the MDD are not affected up to May 26, 2020. I recommend you inform your customers of the potential problem so they can build inventory in the event of a shortage.

First, it is important to note that IM, IS, and IR are not, despite the common usage, classes under the MDR. I have had clients confused by the application of the classification rules in Annex VIII, since they expected a classification of Class IR, say.

The R, S, or M is a requirement of conformity assessment, not of the device class.  For example, there are additional conformity assessment requirements for a Class IIb active device intended to administer and/or remove a medicinal product. We could call them Class IIbM devices.

The point is that the conformity assessment requirements for Class I reusable surgical instruments is in Article 52(7), which requires that the manufacturer apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

Article 52(7.c) says, "However, the involvement of the notified body in those procedures shall be limited, in the case of reusable surgical instruments, 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."

You will need to follow the relevant conformity assessment annex which requires a notified body with limited involvement. The second part, NB, is the source of the problem. Without NB involvement, you will not be able to put the CE Mark on the devices, so, after May 26, 2020 you would not be able place new devices on the EU market.

The Article 120 soft transition would not apply because it requires NB certificates, but you don't have them.

The only hope is that your NB becomes notified under the EU-MDR and has the correct scope for this work.

Products under the MDD are not affected up to May 26, 2020. I recommend you inform your customers of the potential problem so they can build inventory in the event of a shortage.

First, it is important to note that IM, IS, and IR are not, despite the common usage, classes under the MDR. I have had clients confused by the application of the classification rules in Annex VIII, since they expected a classification of Class IR, say.

The R, S, or M is a requirement of conformity assessment, not of the device class.  For example, there are additional conformity assessment requirements for a Class IIb active device intended to administer and/or remove a medicinal product. We could call them Class IIbM devices.

The point is that the conformity assessment requirements for Class I reusable surgical instruments is in Article 52(7), which requires that the manufacturer apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

Article 52(7.c) says, "However, the involvement of the notified body in those procedures shall be limited, in the case of reusable surgical instruments, 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."

You will need to follow the relevant conformity assessment annex which requires a notified body with limited involvement. The second part, NB, is the source of the problem. Without NB involvement, you will not be able to put the CE Mark on the devices, so, after May 26, 2020 you would not be able place new devices on the EU market.

The Article 120 soft transition would not apply because it requires NB certificates, but you don't have them.

The only hope is that your NB becomes notified under the EU-MDR and has the correct scope for this work.

Products under the MDD are not affected up to May 26, 2020. I recommend you inform your customers of the potential problem so they can build inventory in the event of a shortage.

First, it is important to note that IM, IS, and IR are not, despite the common usage, classes under the MDR. I have had clients confused by the application of the classification rules in Annex VIII, since they expected a classification of Class IR, say.

The R, S, or M is a requirement of conformity assessment, not of the device class.  For example, there are additional conformity assessment requirements for a Class IIb active device intended to administer and/or remove a medicinal product. We could call them Class IIbM devices.

The point is that the conformity assessment requirements for Class I reusable surgical instruments is in Article 52(7), which requires that the manufacturer apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

Article 52(7.c) says, "However, the involvement of the notified body in those procedures shall be limited, in the case of reusable surgical instruments, 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."

You will need to follow the relevant conformity assessment annex which requires a notified body with limited involvement. The second part, NB, is the source of the problem. Without NB involvement, you will not be able to put the CE Mark on the devices, so, after May 26, 2020 you would not be able place new devices on the EU market.

The Article 120 soft transition would not apply because it requires NB certificates, but you don't have them.

The only hope is that your NB becomes notified under the EU-MDR and has the correct scope for this work.

Products under the MDD are not affected up to May 26, 2020. I recommend you inform your customers of the potential problem so they can build inventory in the event of a shortage.

First, it is important to note that IM, IS, and IR are not, despite the common usage, classes under the MDR. I have had clients confused by the application of the classification rules in Annex VIII, since they expected a classification of Class IR, say.

The R, S, or M is a requirement of conformity assessment, not of the device class.  For example, there are additional conformity assessment requirements for a Class IIb active device intended to administer and/or remove a medicinal product. We could call them Class IIbM devices.

The point is that the conformity assessment requirements for Class I reusable surgical instruments is in Article 52(7), which requires that the manufacturer apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

Article 52(7.c) says, "However, the involvement of the notified body in those procedures shall be limited, in the case of reusable surgical instruments, 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."

You will need to follow the relevant conformity assessment annex which requires a notified body with limited involvement. The second part, NB, is the source of the problem. Without NB involvement, you will not be able to put the CE Mark on the devices, so, after May 26, 2020 you would not be able place new devices on the EU market.

The Article 120 soft transition would not apply because it requires NB certificates, but you don't have them.

The only hope is that your NB becomes notified under the EU-MDR and has the correct scope for this work.

Products under the MDD are not affected up to May 26, 2020. I recommend you inform your customers of the potential problem so they can build inventory in the event of a shortage.