Regulatory Open Forum

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
------------------------------

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

Evangelos,

This is my own personal opinion, having many discussions with Economic Operators over the last few months has been disagreement and also some on this forum may not agree.  For me Article 120 applies to a EU MDD CE Certificate allowing a product to continue being placed on the market after the compliance date of May 2020.  There is wording in there about no significant changes (which has yet to be clarified) and there is no information about quality systems.  Again from my perspective Article 120 does not apply to obligations required under Article 10, 13, 14, and 16.  These are quality system related activities, not product specific compliance requirements as I would view Article 120 being about the CE Certificate.  I have been approaching Economic Operators telling them obligations under the Articles of EU MDR must be met after May 2020.  Think of it this way - let me give you a scenario.  A Notified Body can no longer audit against EU MDD after 26 May 2020, they will not legally be able to, thus why we have Article 120 to allow placing of product on the market.  I am a manufacturing going through an EU MDR audit August 2020 because I have to "upgrade" to EU MDR as MDD is no longer auditable.  The Notified Body starts asking me many questions about distribution activities, distribution chain, lifecycle of the product, etc.  They find out I have no idea nor any control over the distribution chain.  All those importers and distributors (and AR) can be subject to audits by a Notified Body if the medical device manufacturer does not have the controls in place for post market activities, i.e. complaint handling, complaint reporting, adverse event determination, adverse event, FSCA/recalls.

So I can tell you, we have had those difficult conversations with distributors about getting procedures in place for how complaints are managed or forwarded to the manufacturer.  We have started implementing procedures for FSCA/recall management and what the distributors (and importers) must do on their side.  Again, it is a quality system process having nothing to do with the CE Certificate.  I know others may disagree, but Article 120 is about allowing an EU MDD valid CE Certificate product to continue to be placed on the market, it does not explicit give exemptions for obligations of any Economic Operator (how many times is the word 'certificate' used in Article 120, count it).  The only exception made are those obligations which require use of EUDAMED from Article 123, but we know logistically it would be impossible to follow a regulation where a system does not physically exist.  I think too many people are using Article 120 as a "get out of jail free card" but has nothing to do with obligations of quality system processes.  And yes, those activities being done by AR, importers, and distributors are quality system processes.

Now with that said, there is a lot of discussion around handling both MDD and MDR products in the same distribution chains.  Yes, it is difficult and can be challenging.  Organisations therefore need to establish good, detailed Quality Plans showing how they are managing and controlling (or not controlling EU MDD products) devices through the distribution chain and lifecycle of the device.  The EU MDR was "put in force" May 2017 giving Economic Operators 3 years to get processes in place, that time needs to be used effectively.

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

Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

I had a fully detailed reply to this question which I 'saved as draft', but then disappeared. Any idea how I can retrieve this?

Basically, I agree with Richard - Articles 13, 14 and 16 (along with Articles 10, 11 and 12) cannot in my opinion apply to the manufacture, authorised representation, importation or distribution of 'legacy devices'.

If I can retrieve my earlier draft response, I'll post it.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 22-Jan-2020 05:18
From: Richard Vincins
Subject: Obligations of economic operators after 26.05.2020

Evangelos,

This is my own personal opinion, having many discussions with Economic Operators over the last few months has been disagreement and also some on this forum may not agree.  For me Article 120 applies to a EU MDD CE Certificate allowing a product to continue being placed on the market after the compliance date of May 2020.  There is wording in there about no significant changes (which has yet to be clarified) and there is no information about quality systems.  Again from my perspective Article 120 does not apply to obligations required under Article 10, 13, 14, and 16.  These are quality system related activities, not product specific compliance requirements as I would view Article 120 being about the CE Certificate.  I have been approaching Economic Operators telling them obligations under the Articles of EU MDR must be met after May 2020.  Think of it this way - let me give you a scenario.  A Notified Body can no longer audit against EU MDD after 26 May 2020, they will not legally be able to, thus why we have Article 120 to allow placing of product on the market.  I am a manufacturing going through an EU MDR audit August 2020 because I have to "upgrade" to EU MDR as MDD is no longer auditable.  The Notified Body starts asking me many questions about distribution activities, distribution chain, lifecycle of the product, etc.  They find out I have no idea nor any control over the distribution chain.  All those importers and distributors (and AR) can be subject to audits by a Notified Body if the medical device manufacturer does not have the controls in place for post market activities, i.e. complaint handling, complaint reporting, adverse event determination, adverse event, FSCA/recalls.

So I can tell you, we have had those difficult conversations with distributors about getting procedures in place for how complaints are managed or forwarded to the manufacturer.  We have started implementing procedures for FSCA/recall management and what the distributors (and importers) must do on their side.  Again, it is a quality system process having nothing to do with the CE Certificate.  I know others may disagree, but Article 120 is about allowing an EU MDD valid CE Certificate product to continue to be placed on the market, it does not explicit give exemptions for obligations of any Economic Operator (how many times is the word 'certificate' used in Article 120, count it).  The only exception made are those obligations which require use of EUDAMED from Article 123, but we know logistically it would be impossible to follow a regulation where a system does not physically exist.  I think too many people are using Article 120 as a "get out of jail free card" but has nothing to do with obligations of quality system processes.  And yes, those activities being done by AR, importers, and distributors are quality system processes.

Now with that said, there is a lot of discussion around handling both MDD and MDR products in the same distribution chains.  Yes, it is difficult and can be challenging.  Organisations therefore need to establish good, detailed Quality Plans showing how they are managing and controlling (or not controlling EU MDD products) devices through the distribution chain and lifecycle of the device.  The EU MDR was "put in force" May 2017 giving Economic Operators 3 years to get processes in place, that time needs to be used effectively.

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

Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

​I agree with previous contributions that the articles 10 to 16 are not applicable when using the transitional provisions in article 120. Out of curiosity, why is article 15 on the Person Responsible for Regulatory Compliance left out in the listing?
Even under the MDD a manufacturer should have agreements and controls in place to manage importers, distributors and authorised representative, when applicable. The manufacturer was and is responsible for the medical device up and until use, including the supply chain. The contents of those agreements and controls however where not identified in the MDD.

My point is that a manufacturer using the transitional provisions of the MDR should be prepared for future full compliance with the MDR and have a plan in place towards that level of compliance. Compliance with the MDR requirements for post-market surveillance, market surveillance, vigilance and registration of economic operators should be in place on May 26, 2020 and is the first milestone. The rest follows in a suitable pace but at the latest before the first MDR CE-marking of a product.
For class I products (except those to be up-classified) the plan ends at May 26, 2020, they cannot use the transitional provisions.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
------------------------------

Original Message:
Sent: 22-Jan-2020 05:32
From: Roger Gray
Subject: Obligations of economic operators after 26.05.2020

I had a fully detailed reply to this question which I 'saved as draft', but then disappeared. Any idea how I can retrieve this?

Basically, I agree with Richard - Articles 13, 14 and 16 (along with Articles 10, 11 and 12) cannot in my opinion apply to the manufacture, authorised representation, importation or distribution of 'legacy devices'.

If I can retrieve my earlier draft response, I'll post it.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 22-Jan-2020 05:18
From: Richard Vincins
Subject: Obligations of economic operators after 26.05.2020

Evangelos,

This is my own personal opinion, having many discussions with Economic Operators over the last few months has been disagreement and also some on this forum may not agree.  For me Article 120 applies to a EU MDD CE Certificate allowing a product to continue being placed on the market after the compliance date of May 2020.  There is wording in there about no significant changes (which has yet to be clarified) and there is no information about quality systems.  Again from my perspective Article 120 does not apply to obligations required under Article 10, 13, 14, and 16.  These are quality system related activities, not product specific compliance requirements as I would view Article 120 being about the CE Certificate.  I have been approaching Economic Operators telling them obligations under the Articles of EU MDR must be met after May 2020.  Think of it this way - let me give you a scenario.  A Notified Body can no longer audit against EU MDD after 26 May 2020, they will not legally be able to, thus why we have Article 120 to allow placing of product on the market.  I am a manufacturing going through an EU MDR audit August 2020 because I have to "upgrade" to EU MDR as MDD is no longer auditable.  The Notified Body starts asking me many questions about distribution activities, distribution chain, lifecycle of the product, etc.  They find out I have no idea nor any control over the distribution chain.  All those importers and distributors (and AR) can be subject to audits by a Notified Body if the medical device manufacturer does not have the controls in place for post market activities, i.e. complaint handling, complaint reporting, adverse event determination, adverse event, FSCA/recalls.

So I can tell you, we have had those difficult conversations with distributors about getting procedures in place for how complaints are managed or forwarded to the manufacturer.  We have started implementing procedures for FSCA/recall management and what the distributors (and importers) must do on their side.  Again, it is a quality system process having nothing to do with the CE Certificate.  I know others may disagree, but Article 120 is about allowing an EU MDD valid CE Certificate product to continue to be placed on the market, it does not explicit give exemptions for obligations of any Economic Operator (how many times is the word 'certificate' used in Article 120, count it).  The only exception made are those obligations which require use of EUDAMED from Article 123, but we know logistically it would be impossible to follow a regulation where a system does not physically exist.  I think too many people are using Article 120 as a "get out of jail free card" but has nothing to do with obligations of quality system processes.  And yes, those activities being done by AR, importers, and distributors are quality system processes.

Now with that said, there is a lot of discussion around handling both MDD and MDR products in the same distribution chains.  Yes, it is difficult and can be challenging.  Organisations therefore need to establish good, detailed Quality Plans showing how they are managing and controlling (or not controlling EU MDD products) devices through the distribution chain and lifecycle of the device.  The EU MDR was "put in force" May 2017 giving Economic Operators 3 years to get processes in place, that time needs to be used effectively.

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

Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

No, as far as I can tell, "saved" drafts are essentially not retrievable.  I think there was one quirky situation in which posts in progress were being lost, and that "saving" your post as a draft might actually save it, but otherwise, no.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jan-2020 05:32
From: Roger Gray
Subject: Obligations of economic operators after 26.05.2020

I had a fully detailed reply to this question which I 'saved as draft', but then disappeared. Any idea how I can retrieve this?

Basically, I agree with Richard - Articles 13, 14 and 16 (along with Articles 10, 11 and 12) cannot in my opinion apply to the manufacture, authorised representation, importation or distribution of 'legacy devices'.

If I can retrieve my earlier draft response, I'll post it.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 22-Jan-2020 05:18
From: Richard Vincins
Subject: Obligations of economic operators after 26.05.2020

Evangelos,

This is my own personal opinion, having many discussions with Economic Operators over the last few months has been disagreement and also some on this forum may not agree.  For me Article 120 applies to a EU MDD CE Certificate allowing a product to continue being placed on the market after the compliance date of May 2020.  There is wording in there about no significant changes (which has yet to be clarified) and there is no information about quality systems.  Again from my perspective Article 120 does not apply to obligations required under Article 10, 13, 14, and 16.  These are quality system related activities, not product specific compliance requirements as I would view Article 120 being about the CE Certificate.  I have been approaching Economic Operators telling them obligations under the Articles of EU MDR must be met after May 2020.  Think of it this way - let me give you a scenario.  A Notified Body can no longer audit against EU MDD after 26 May 2020, they will not legally be able to, thus why we have Article 120 to allow placing of product on the market.  I am a manufacturing going through an EU MDR audit August 2020 because I have to "upgrade" to EU MDR as MDD is no longer auditable.  The Notified Body starts asking me many questions about distribution activities, distribution chain, lifecycle of the product, etc.  They find out I have no idea nor any control over the distribution chain.  All those importers and distributors (and AR) can be subject to audits by a Notified Body if the medical device manufacturer does not have the controls in place for post market activities, i.e. complaint handling, complaint reporting, adverse event determination, adverse event, FSCA/recalls.

So I can tell you, we have had those difficult conversations with distributors about getting procedures in place for how complaints are managed or forwarded to the manufacturer.  We have started implementing procedures for FSCA/recall management and what the distributors (and importers) must do on their side.  Again, it is a quality system process having nothing to do with the CE Certificate.  I know others may disagree, but Article 120 is about allowing an EU MDD valid CE Certificate product to continue to be placed on the market, it does not explicit give exemptions for obligations of any Economic Operator (how many times is the word 'certificate' used in Article 120, count it).  The only exception made are those obligations which require use of EUDAMED from Article 123, but we know logistically it would be impossible to follow a regulation where a system does not physically exist.  I think too many people are using Article 120 as a "get out of jail free card" but has nothing to do with obligations of quality system processes.  And yes, those activities being done by AR, importers, and distributors are quality system processes.

Now with that said, there is a lot of discussion around handling both MDD and MDR products in the same distribution chains.  Yes, it is difficult and can be challenging.  Organisations therefore need to establish good, detailed Quality Plans showing how they are managing and controlling (or not controlling EU MDD products) devices through the distribution chain and lifecycle of the device.  The EU MDR was "put in force" May 2017 giving Economic Operators 3 years to get processes in place, that time needs to be used effectively.

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

Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

Original Message------

No, as far as I can tell, "saved" drafts are essentially not retrievable.  I think there was one quirky situation in which posts in progress were being lost, and that "saving" your post as a draft might actually save it, but otherwise, no.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

This message was posted by a user wishing to remain anonymous

​Paragraph 1 of Article 13 states that Importers shall only place on the market devices that are in conformity with the MDR regulation.

Article 120(3) states that you can continue to place your MDD device on the market provided you have a valid cert (para. 2) and you don't make significant changes, and you continue to comply with the MDD. (of course, the manf must still implement the postmarket surveillance, market surveillance, and vigilance per this same paragraph.  Registration of economic operators will be dictated by EUDAMED, which is currently delayed 2 yrs).

Therefore, we have interpreted this to understand that if we are continuing to market our device under MDD, then it is not applicable to paragraph 1 of the Importer article and the Importer does not have to meet those requirements for the MDD device.
Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

Indeed, Anonymous. Articles 13 and 14 contain explicit requirements that can apply only when importers and distributors are receiving MDR-compliant devices. It seems incorrect to argue that these Articles apply to legacy devices, since it is not possible to apply all the requirements listed. You can't have a 'half way' situation where someone decides that certain requirements apply and not others, unless this is explicitly stated somewhere in the MDR.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 21-Jan-2020 18:55
From: Anonymous Member
Subject: Obligations of economic operators after 26.05.2020

This message was posted by a user wishing to remain anonymous

​Paragraph 1 of Article 13 states that Importers shall only place on the market devices that are in conformity with the MDR regulation.

Article 120(3) states that you can continue to place your MDD device on the market provided you have a valid cert (para. 2) and you don't make significant changes, and you continue to comply with the MDD. (of course, the manf must still implement the postmarket surveillance, market surveillance, and vigilance per this same paragraph.  Registration of economic operators will be dictated by EUDAMED, which is currently delayed 2 yrs).

Therefore, we have interpreted this to understand that if we are continuing to market our device under MDD, then it is not applicable to paragraph 1 of the Importer article and the Importer does not have to meet those requirements for the MDD device.
Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

There follows my initial response, intended to be uploaded about 7 hours ago. Thanks to Emily at RAPS for advising how to retrieve a draft!

Sorry to disagree, guys, but there is nothing in the MDR that states that Articles 13, 14, 15 and 16 apply to 'legacy devices' that continue to be placed on the EU market in accordance with the derogation in Article 120(3) per Corrigendum 2, now that Eudamed has been delayed.

Note that Article 5 requires that "A device may be placed on the market or put into service only if it complies with this Regulation . . .", and that Article 120(3) applies as a "derogation from Article 5". This implies (accepting it is not explicit) that by derogating from Article 5, Article 120(3) also derogates legacy devices from all other articles of the MDR, unless specifically required, as is the case with the final sentence of Article 120(3), which is now moot because of the unavailability of Eudamed (per Annex 123(3)(d) final bullet point).

Thus Articles 10, 11, 12, 13, 14, 15 and 16 apply only to the manufacture, authorised representation, importation and distribution of MDR-compliant devices. I include Articles 10, 11, 12 and 15 here because if one accepts the argument that Articles 13, 14 and 16 apply to legacy devices, what is the reasoning not to include Articles 10, 11, 12 and 15 in this conclusion as well? I am aware of at least one competent authority that has made this argument, but this cannot be true when Article 10 requires manufacturers, among other things, to conduct a clinical evaluation in accordance with MDR Article 61 and Annex XIV, prepare technical documentation in accordance with MDR Annexes II and III, and "comply with the obligations relating to the UDI system referred to in Article 27". If manufacturers did all of this, they would have MDR-compliant devices, not legacy devices.

On this last point, in the guidance document MDCG 2019-5, 'Registration of legacy devices in EUDAMED', it is stated that "The MDR is not explicit in requiring that these "legacy devices" are subject to relevant UDI obligations", thus is is clear that Article 10 does not apply to manufacturers who are placing legacy devices on the EU market under the MDD/AIMDD, otherwise this statement in the guidance would be untrue. This guidance goes on to explain a scheme, now also moot, to allow legacy devices to be registered with a false UDI-DI, the so-called 'Eudamed DI', because of this lack of requirement in the MDR for legacy device UDI registration.

If it is clear that if Article 10 cannot apply to manufacturers of legacy devices, any argument that Articles 11, 12, 13, 14, 15 and 16 apply to authorised representatives, importers and distributors who further the distribution of only legacy devices, is very weak. Remember that legacy devices are explicitly derogated from Article 5, meaning that they are derogated from having to meet any part of the MDR except for the (now moot) final sentence of Article 120(3). The requirements of Articles 11, 12, 13, 14, 15 and 16 therefore kick in only when MDR-compliant devices are being placed and distributed on the EU market as a result of a manufacturer complying with his obligations under Article 10.

That's my reasoned understanding, anyway. This argument has also been accepted by certain industry associations and NBs.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

Hi Roger and Richard 
Thank you for yours detailed explanation (with follow-up to other MDR articles).
It sounds reasonable to me personally, and I am in favour of yours conclusions as to the obligation of importers and distributors versus legacy devices under MDD.
So, generally I agree with both  - Articles 13, 14 and 16 (along with Articles 10, 11 and 12) cannot apply to the manufacture, authorised representation, importation or distribution of 'legacy devices'.

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

Original Message:
Sent: 22-Jan-2020 11:14
From: Roger Gray
Subject: Obligations of economic operators after 26.05.2020

There follows my initial response, intended to be uploaded about 7 hours ago. Thanks to Emily at RAPS for advising how to retrieve a draft!

Sorry to disagree, guys, but there is nothing in the MDR that states that Articles 13, 14, 15 and 16 apply to 'legacy devices' that continue to be placed on the EU market in accordance with the derogation in Article 120(3) per Corrigendum 2, now that Eudamed has been delayed.

Note that Article 5 requires that "A device may be placed on the market or put into service only if it complies with this Regulation . . .", and that Article 120(3) applies as a "derogation from Article 5". This implies (accepting it is not explicit) that by derogating from Article 5, Article 120(3) also derogates legacy devices from all other articles of the MDR, unless specifically required, as is the case with the final sentence of Article 120(3), which is now moot because of the unavailability of Eudamed (per Annex 123(3)(d) final bullet point).

Thus Articles 10, 11, 12, 13, 14, 15 and 16 apply only to the manufacture, authorised representation, importation and distribution of MDR-compliant devices. I include Articles 10, 11, 12 and 15 here because if one accepts the argument that Articles 13, 14 and 16 apply to legacy devices, what is the reasoning not to include Articles 10, 11, 12 and 15 in this conclusion as well? I am aware of at least one competent authority that has made this argument, but this cannot be true when Article 10 requires manufacturers, among other things, to conduct a clinical evaluation in accordance with MDR Article 61 and Annex XIV, prepare technical documentation in accordance with MDR Annexes II and III, and "comply with the obligations relating to the UDI system referred to in Article 27". If manufacturers did all of this, they would have MDR-compliant devices, not legacy devices.

On this last point, in the guidance document MDCG 2019-5, 'Registration of legacy devices in EUDAMED', it is stated that "The MDR is not explicit in requiring that these "legacy devices" are subject to relevant UDI obligations", thus is is clear that Article 10 does not apply to manufacturers who are placing legacy devices on the EU market under the MDD/AIMDD, otherwise this statement in the guidance would be untrue. This guidance goes on to explain a scheme, now also moot, to allow legacy devices to be registered with a false UDI-DI, the so-called 'Eudamed DI', because of this lack of requirement in the MDR for legacy device UDI registration.

If it is clear that if Article 10 cannot apply to manufacturers of legacy devices, any argument that Articles 11, 12, 13, 14, 15 and 16 apply to authorised representatives, importers and distributors who further the distribution of only legacy devices, is very weak. Remember that legacy devices are explicitly derogated from Article 5, meaning that they are derogated from having to meet any part of the MDR except for the (now moot) final sentence of Article 120(3). The requirements of Articles 11, 12, 13, 14, 15 and 16 therefore kick in only when MDR-compliant devices are being placed and distributed on the EU market as a result of a manufacturer complying with his obligations under Article 10.

That's my reasoned understanding, anyway. This argument has also been accepted by certain industry associations and NBs.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 21-Jan-2020 05:59
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Hi Peter
thank you for your contribution.
From my point of view, and I agree with you , both importers and distributors must be prepared to comply with the obligations of MDR Articles 13, 14 and 16 (Action Plan,…) after 26.5.2020, regardless of whether it will be devices under MDD or MDR, because there is no specified transition period for requests for these economic operators.
Unfortunately, the MDCG group gave no intrusions or explanations.

Evangelos

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

Original Message:
Sent: 21-Jan-2020 02:58
From: Peter Reijntjes
Subject: Obligations of economic operators after 26.05.2020

​Dear Evangelos,
Indeed the purpose of article 120 (as amended in corrigendum II) is to provide transitional provisions as defined and not more. I know and you can find other discussions on this forum, that other interpretations are put forward; this is my interpretation, otherwise it would not have been stated like it is. But…..
E.g. registration of Economic operators (including the PRRC) and nothing more sounds a bit silly to me; you identify and register responsible entities and persons, but do not implement the associated responsibilities......

Only implementing the requirements of article 120(3) and nothing more will also mean that a manufacturer (and other economic operators) will face a problem when the manufacturer wants to bring a product onto the market under full MDR compliance. Suddenly also all those 'other requirements' are applicable and should have been defined, agreed, documented and implemented. This is not a situation a manufacturer wants to face. ISO 13485 also pays attention to this and requires to be prepared for 'changes that could affect the quality management system' (clause 5.6).

So I would not wait and make an action plan and start identifying and implementing all the 'other requirements left' to be prepared for full MDR compliance. it is my assumption that upgrade to MDR does not interfere with requirements of MDD and therefore does not jeopardise MDD compliance. Not being prepared and not having a plan can even lead to a nonconformity during the Notified Body audits.

In short, 'at least' the requirements of article 120 and actions underway and fulfilled according a sound quality plan aligned with the productportfolio plan.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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

I view the MDR Article 120 transition as a modification of the MDD. Think of the EU-MDD as made up of modules. Article 120 unplugs some of the MDD modules and replaces them with MDR modules. In other cases, Article 120 plugs in new modules that are not in the MDD.

The result is a modified MDD. I think it is important to state this on any declaration of conformity. Under Article 120 the manufacturer is operating under the MDD as modified by MDR Article 120.

The problem comes up because Article 120 has explicit requirements that lead to implicit requirements. For example, there is a new requirement to register economic operators. For the manufacturer this includes identifying the person responsible.

Registering an economic operator means that the economic operators have a Single Registration Number, SRN and have populated EUDAMED. Similarly, for person responsible, the manufacturer must have designated at least one person.

For economic operators, they exist under MDD and provide outsourced processes to the manufacturer under ISO 13485:2016.

For devices under MDD as modified by MDR Article 120 the economic operator MDR requirements in their respective articles do not apply.

For devices under full MDR, the economic operator MDR requirements do apply.

For a manufacturer for whom both conditions apply, follow the MDR requirements.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 21-Jan-2020 01:33
From: Evangelos Tavandzis
Subject: Obligations of economic operators after 26.05.2020

Dear colleagues,
it is not clear to me whether the obligations laid down in Articles 13, 14 and 16  for importers and distributors also apply to so called  "legacy devices" which will be launched and put into service with an (MDD) EC certificate by 2024 or only for MDR-compliant devices , after 26.05.2020. This is not  clarified in Article 120. What do you think?

Thank you.
Evangelos



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