Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR. 

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.

Hi Anon
attached please find MDCG document


------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 06-Oct-2020 11:38
From: Anonymous Member
Subject: MDR significant change

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR.

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.

Hi
from my point of view, this Guide can also be used for MDR until another will be  released for MDR

------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 07-Oct-2020 01:01
From: Evangelos Tavandzis
Subject: MDR significant change

Hi Anon
attached please find MDCG document

------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic

Original Message:
Sent: 06-Oct-2020 11:38
From: Anonymous Member
Subject: MDR significant change

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR.

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.

Hi Anon,

1. MDCG 2020-3 is a guideline not only for legacy devices, but for all devices regulated under MDD/AIMD during the transition period.
2. You are right. This guide is not supposed to be used for the significant changes on MDR
3. There is no requirement for including the procedure for these changes in your NB contract. It is usually described in an internal procedure of the manufacturer.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 06-Oct-2020 11:38
From: Anonymous Member
Subject: MDR significant change

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR.

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.

Hi,

the certification agreement between the manufacturer and the notified body originally signed years ago under the MDD must in allmost allcases be updated, because it this agreement does NOT cover the grace period during which no MDD notified bodies exist any more. We understand, that the new certification agreement for the grace period could/will make a refrence to the very important document MDCG 2020-3.

------------------------------
Klaus-Dieter Ziel
Hamburg
Germany
------------------------------

Original Message:
Sent: 07-Oct-2020 01:56
From: Spyros Drivelos
Subject: MDR significant change

Hi Anon,

1. MDCG 2020-3 is a guideline not only for legacy devices, but for all devices regulated under MDD/AIMD during the transition period.
2. You are right. This guide is not supposed to be used for the significant changes on MDR
3. There is no requirement for including the procedure for these changes in your NB contract. It is usually described in an internal procedure of the manufacturer.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 06-Oct-2020 11:38
From: Anonymous Member
Subject: MDR significant change

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR.

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.

Hello Anon,

Like under the EU MDD in most cases significant change definition would be described by the Notified Bodies.  It would be great if in the future we can get a MDCG guidance document similar to 2020-3 and similar to FDA's guidance on changes because there is not a consistent implementation of "significant change" by all Notified Bodies.  This significant change notification should be at an EU level, not a Notified Body level.  Until there is a further guidance through MDCG or the Commission, most of the significant changes would be viewed by the Notified Bodies.  It is not clear if the NB-MED guidance would be updated or not - and keep in mind this document was not written for manufacturer, it was written for Notified Bodies.

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

Original Message:
Sent: 07-Oct-2020 04:42
From: Klaus-Dieter Ziel
Subject: MDR significant change

Hi,

the certification agreement between the manufacturer and the notified body originally signed years ago under the MDD must in allmost allcases be updated, because it this agreement does NOT cover the grace period during which no MDD notified bodies exist any more. We understand, that the new certification agreement for the grace period could/will make a refrence to the very important document MDCG 2020-3.

------------------------------
Klaus-Dieter Ziel
Hamburg
Germany

Original Message:
Sent: 07-Oct-2020 01:56
From: Spyros Drivelos
Subject: MDR significant change

Hi Anon,

1. MDCG 2020-3 is a guideline not only for legacy devices, but for all devices regulated under MDD/AIMD during the transition period.
2. You are right. This guide is not supposed to be used for the significant changes on MDR
3. There is no requirement for including the procedure for these changes in your NB contract. It is usually described in an internal procedure of the manufacturer.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 06-Oct-2020 11:38
From: Anonymous Member
Subject: MDR significant change

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR.

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.

I created the attached memo template for all product changes to provide evidence why or why not any change is substantial per MDR.

------------------------------
Edward Panek
VP, QA/RA
Blue Spark Technologies
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 06-Oct-2020 11:38
From: Anonymous Member
Subject: MDR significant change

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR.

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.

This message was posted by a user wishing to remain anonymous

Hello,

1/ For your first question the answer is YES, as indicate by the title of the MDCG 2020-3 (Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD) This guidance is only for the transition period.
2/ For your second question, the answer is also YES
3/ For your third question, the answer is also YES and you have another document from NBOG that may be usefull: http://www.doks.nbog.eu/Doks/NBOG_BPG_2014_3.pdf
Original Message:
Sent: 06-Oct-2020 11:38
From: Anonymous Member
Subject: MDR significant change

This message was posted by a user wishing to remain anonymous

Hi everyone,

I am trying to develop our change control process for significant changes under MDR.

If someone could confirm my understanding of the points below, I would appreciate that:

1. The MDCG 2020-3 guidance applies to significant changes in the context of the transition from legacy device regulated under MDD/AIMD to MDR. The MDCG 2020-3 guidance does NOT apply to determining significant changes of products CE marked under MDR.
2. Which changes need to get reported to your Notified Body is set in the contract you have with your Notified Body. Notified Bodies use the NB-MED/2.5.2/Rec2 guidance for this and we (manufacturers) can use this guidance to determine our change control process.
3. Is this the current version of the NB guidance? https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf 

Thank you.