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This message was posted by a user wishing to remain anonymous

Hello all,

With the upcoming EU MDR regulations, I would like to confirm if Class IIa and IIb also require prior approval from the EU Notified Body or will they fall under the self -certified class of devices?

Do we need to have EC Design Certificate for Class IIa and IIb in EU MDR ?

Thank you.

EU MDR Class IIa and IIb devices require Notified Body (NB) involvement.  This means that the self-declaration route is not available for class IIa or IIb devices.  Here is a summary of the associated Notified Body assessment and certification requirements for EU MDR Class IIa and IIb devices:

For Class IIa, there are three conformity assessment routes and associated certification scenarios from which to choose:

 

• Full QMS (Annex IX Chapters I and III) where the NB assesses the full QMS (e.g., design plus production) and the Technical Documentation (TD). These NB assessments result in an EU Quality Management System Certificate and an EU Technical Documentation Certificate.
• Production QMS (Annex XI Part A / Section 10) where the NB assesses the production QMS (excluding design) and the TD. These NB assessments result in an EU Quality Assurance Certificate and an EU Technical Documentation Certificate.
• Product Verification (Annex XI Part B / Section 18) where the NB assesses the TD resulting in an EU Technical Documentation Certificate.

 

For Class IIb, there are two conformity assessment routes and associated certification scenarios from which to choose:

 

• Full QMS (Annex IX Chapters I and III) where the NB assesses the full QMS (e.g., design plus production) and the TD. These NB assessments result in an EU Quality Management System Certificate and an EU Technical Documentation Certificate.
• NB Type Examination (Annex X) coupled with Product Verification (Annex XI Part B) where the NB performs Type-Examination (resulting in an EU Type-Examination Certificate) and, for every device individually, also performs examinations and tests resulting in an EU Product Verification Certificate.

 

 Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 09-Nov-2020 15:26
From: Anonymous Member
Subject: EU MDR Classification

This message was posted by a user wishing to remain anonymous

Hello all,

With the upcoming EU MDR regulations, I would like to confirm if Class IIa and IIb also require prior approval from the EU Notified Body or will they fall under the self -certified class of devices?

Do we need to have EC Design Certificate for Class IIa and IIb in EU MDR ?

Thank you.

Hello Anon,

Class IIa and IIb devices require Notified Body intervention for review and approval of QMS and technical documentation in order to obtain a CE Certificate.  Class I devices which are non-sterile, non-measuring, and non-reusable surgical instruments are so-called "self declare" and do not require Notified Body intervention.  The Class I sterile, measuring, and reusable surgical instruments and of course Class III devices also require a Notified Body review.  There is no such thing as an EC Design Certificate under the EU MDR now, all medical devices reviewed by a Notified Body have the quality system assessed and the technical documentation reviewed.  There are many more documents, plans, and reports needed under the EU MDR which should be covered in your quality management system.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 09-Nov-2020 17:32
From: Kevin Randall
Subject: EU MDR Classification

EU MDR Class IIa and IIb devices require Notified Body (NB) involvement.  This means that the self-declaration route is not available for class IIa or IIb devices.  Here is a summary of the associated Notified Body assessment and certification requirements for EU MDR Class IIa and IIb devices:

For Class IIa, there are three conformity assessment routes and associated certification scenarios from which to choose:

 

• Full QMS (Annex IX Chapters I and III) where the NB assesses the full QMS (e.g., design plus production) and the Technical Documentation (TD). These NB assessments result in an EU Quality Management System Certificate and an EU Technical Documentation Certificate.
• Production QMS (Annex XI Part A / Section 10) where the NB assesses the production QMS (excluding design) and the TD. These NB assessments result in an EU Quality Assurance Certificate and an EU Technical Documentation Certificate.
• Product Verification (Annex XI Part B / Section 18) where the NB assesses the TD resulting in an EU Technical Documentation Certificate.

 

For Class IIb, there are two conformity assessment routes and associated certification scenarios from which to choose:

 

• Full QMS (Annex IX Chapters I and III) where the NB assesses the full QMS (e.g., design plus production) and the TD. These NB assessments result in an EU Quality Management System Certificate and an EU Technical Documentation Certificate.
• NB Type Examination (Annex X) coupled with Product Verification (Annex XI Part B) where the NB performs Type-Examination (resulting in an EU Type-Examination Certificate) and, for every device individually, also performs examinations and tests resulting in an EU Product Verification Certificate.

 

 Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 09-Nov-2020 15:26
From: Anonymous Member
Subject: EU MDR Classification

This message was posted by a user wishing to remain anonymous

Hello all,

With the upcoming EU MDR regulations, I would like to confirm if Class IIa and IIb also require prior approval from the EU Notified Body or will they fall under the self -certified class of devices?

Do we need to have EC Design Certificate for Class IIa and IIb in EU MDR ?

Thank you.