Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All,

Under EU MDR, does notified body involvement and certification required for Class Ir but non-surgical devices; like devices that can be used directly by the user without the support of a healthcare professional by washing/cleaning them after each use (re-usable medical masks, re-usable bladder pads etc.).

Many thanks,

Dear anon,

the requirements for notified body involvement for re-usable devices are indeed limited to re-usable surgical devices.
Article 52.7: Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those 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.

That is, if the re-usable device is a class I device. Note there is no such thing is class Ir devices, just class I devices which are reusable surgical instruments.

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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
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Original Message:
Sent: 06-Apr-2022 02:23
From: Anonymous Member
Subject: Class I reusable, non-surgical

This message was posted by a user wishing to remain anonymous

Dear All,

Under EU MDR, does notified body involvement and certification required for Class Ir but non-surgical devices; like devices that can be used directly by the user without the support of a healthcare professional by washing/cleaning them after each use (re-usable medical masks, re-usable bladder pads etc.).

Many thanks,

This message was posted by a user wishing to remain anonymous

Thank you Peter and Michelle! This confirmed our interpretation.
Original Message:
Sent: 06-Apr-2022 07:14
From: Peter Reijntjes
Subject: Class I reusable, non-surgical

Dear anon,

the requirements for notified body involvement for re-usable devices are indeed limited to re-usable surgical devices.
Article 52.7: Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those 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.

That is, if the re-usable device is a class I device. Note there is no such thing is class Ir devices, just class I devices which are reusable surgical instruments.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands

Original Message:
Sent: 06-Apr-2022 02:23
From: Anonymous Member
Subject: Class I reusable, non-surgical

This message was posted by a user wishing to remain anonymous

Dear All,

Under EU MDR, does notified body involvement and certification required for Class Ir but non-surgical devices; like devices that can be used directly by the user without the support of a healthcare professional by washing/cleaning them after each use (re-usable medical masks, re-usable bladder pads etc.).

Many thanks,

Good Morning,

No you do not need a NB;  you only need an AR and a complete technical file. The requirement for NB is strictly limited to surgical devices, not all reusable medical devices.  We currently have an AR and full technical files for our products which are reusable but not surgical instruments.

Best regards,

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D Michelle Williams
VP - Operations
United States
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Original Message:
Sent: 06-Apr-2022 02:23
From: Anonymous Member
Subject: Class I reusable, non-surgical

This message was posted by a user wishing to remain anonymous

Dear All,

Under EU MDR, does notified body involvement and certification required for Class Ir but non-surgical devices; like devices that can be used directly by the user without the support of a healthcare professional by washing/cleaning them after each use (re-usable medical masks, re-usable bladder pads etc.).

Many thanks,

For info: In MDCG 2021-24 Guidance on classification of medical devices, a Reusable surgical instrument is:

An instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

------------------------------
Stuart March
Chester Le Street
United Kingdom
------------------------------

Original Message:
Sent: 06-Apr-2022 02:23
From: Anonymous Member
Subject: Class I reusable, non-surgical

This message was posted by a user wishing to remain anonymous

Dear All,

Under EU MDR, does notified body involvement and certification required for Class Ir but non-surgical devices; like devices that can be used directly by the user without the support of a healthcare professional by washing/cleaning them after each use (re-usable medical masks, re-usable bladder pads etc.).

Many thanks,