Regulatory Open Forum

I have some questions to the interpretation and application of the consultation procedure according article 54 section1 for class IIb devices falling under rule 12. 

MDR Article 52 section 4 requires in general the manufacture of class IIb products to perform a conformity assessment acc. Annex IX Chapter I (QMS assessment) and assessment of the TD as section 4 of Annex IX for one representative device per generic device group. It also includes requirements for class IIb implantable devices.

MDR Article 54 section 1 require, that in addition to Article 52, a notified body shall perform the consultation procedure acc. Section 5.1 of Annex IX , when the NB is performing a conformity assessment.

So Article 54 section 1 contains explicitly an additional special condition "when performing a conformity assessment of the following devices: [..]". To our understanding this additional condition is very important and we assume it has been placed in the MDR very meaningful, as such conditions are not present in Article 52 section 9 and 10 when demanding special procedures according 5.2 or 5.3 of Annex IX.

 Our interpretation of Article 54 (1) in combination with Article 52 (4) for products of Class IIb falling under rule 12 is that the consultation procedure according 5.1 of Annex IX is only applicable as part of the sampling activities of the NB for evaluation of the technical documentation as it takes place for the first assessment and any further surveillance assessments.

We found as well in the MDCG guideline 2019-13, chapter 5.3 the following interpretation, which we cannot understand:

"According to Article 54, Class IIb active devices intended to administer and/or remove a medicinal product falling into rule 12 of Annex VIII are subject to the clinical evaluation consultation procedure prior to issuing of the certificate. These devices can be subject to sampling but according to Articles 54(3) and 55 the notified body must ensure that at least the clinical evaluation assessment report (CEAR) for each device is uploaded in Eudamed prior to issuing the QMS certificate. This means that the sampling will not apply to the clinical evaluation as it has to be assessed for every device."

In our understanding of the underlined sentence, Article 54(3) and 55 do neither require an assessment for every product!  Article 54(3) just states that a notification has to be given, in case the consultation procedure has been applied. Article 55 states that the CA has to be informed about certificates granted on conformity assessments with the consultation procedure; which, in our understanding, do not replaces or overrules the sampling requirement of article 52 (4).

There for we cannot understand the conclusion, which has been written in the last sentence of that paragraph in MDCG 2019-13.

So far we did not get any clarification from our NB on that question, therefore I would like to put this question here in the forum.

Is this interpretation correct? Are there further requirements in the MDR that we overlook? Has anyone also experience on that questions with their NB? Has anyone some more background on the consultation procedure or the MDCG 2019-13?

Thanks a lot for any feedback or comment on this topic.

I have some questions to the interpretation and application of the consultation procedure according article 54 section1 for class IIb devices falling under rule 12. 

MDR Article 52 section 4 requires in general the manufacture of class IIb products to perform a conformity assessment acc. Annex IX Chapter I (QMS assessment) and assessment of the TD as section 4 of Annex IX for one representative device per generic device group. It also includes requirements for class IIb implantable devices.

MDR Article 54 section 1 require, that in addition to Article 52, a notified body shall perform the consultation procedure acc. Section 5.1 of Annex IX , when the NB is performing a conformity assessment.

So Article 54 section 1 contains explicitly an additional special condition "when performing a conformity assessment of the following devices: [..]". To our understanding this additional condition is very important and we assume it has been placed in the MDR very meaningful, as such conditions are not present in Article 52 section 9 and 10 when demanding special procedures according 5.2 or 5.3 of Annex IX.

 Our interpretation of Article 54 (1) in combination with Article 52 (4) for products of Class IIb falling under rule 12 is that the consultation procedure according 5.1 of Annex IX is only applicable as part of the sampling activities of the NB for evaluation of the technical documentation as it takes place for the first assessment and any further surveillance assessments.

We found as well in the MDCG guideline 2019-13, chapter 5.3 the following interpretation, which we cannot understand:

"According to Article 54, Class IIb active devices intended to administer and/or remove a medicinal product falling into rule 12 of Annex VIII are subject to the clinical evaluation consultation procedure prior to issuing of the certificate. These devices can be subject to sampling but according to Articles 54(3) and 55 the notified body must ensure that at least the clinical evaluation assessment report (CEAR) for each device is uploaded in Eudamed prior to issuing the QMS certificate. This means that the sampling will not apply to the clinical evaluation as it has to be assessed for every device."

In our understanding of the underlined sentence, Article 54(3) and 55 do neither require an assessment for every product!  Article 54(3) just states that a notification has to be given, in case the consultation procedure has been applied. Article 55 states that the CA has to be informed about certificates granted on conformity assessments with the consultation procedure; which, in our understanding, do not replaces or overrules the sampling requirement of article 52 (4).

There for we cannot understand the conclusion, which has been written in the last sentence of that paragraph in MDCG 2019-13.

So far we did not get any clarification from our NB on that question, therefore I would like to put this question here in the forum.

Is this interpretation correct? Are there further requirements in the MDR that we overlook? Has anyone also experience on that questions with their NB? Has anyone some more background on the consultation procedure or the MDCG 2019-13?

Thanks a lot for any feedback or comment on this topic.

I have some questions to the interpretation and application of the consultation procedure according article 54 section1 for class IIb devices falling under rule 12. 

MDR Article 52 section 4 requires in general the manufacture of class IIb products to perform a conformity assessment acc. Annex IX Chapter I (QMS assessment) and assessment of the TD as section 4 of Annex IX for one representative device per generic device group. It also includes requirements for class IIb implantable devices.

MDR Article 54 section 1 require, that in addition to Article 52, a notified body shall perform the consultation procedure acc. Section 5.1 of Annex IX , when the NB is performing a conformity assessment.

So Article 54 section 1 contains explicitly an additional special condition "when performing a conformity assessment of the following devices: [..]". To our understanding this additional condition is very important and we assume it has been placed in the MDR very meaningful, as such conditions are not present in Article 52 section 9 and 10 when demanding special procedures according 5.2 or 5.3 of Annex IX.

 Our interpretation of Article 54 (1) in combination with Article 52 (4) for products of Class IIb falling under rule 12 is that the consultation procedure according 5.1 of Annex IX is only applicable as part of the sampling activities of the NB for evaluation of the technical documentation as it takes place for the first assessment and any further surveillance assessments.

We found as well in the MDCG guideline 2019-13, chapter 5.3 the following interpretation, which we cannot understand:

"According to Article 54, Class IIb active devices intended to administer and/or remove a medicinal product falling into rule 12 of Annex VIII are subject to the clinical evaluation consultation procedure prior to issuing of the certificate. These devices can be subject to sampling but according to Articles 54(3) and 55 the notified body must ensure that at least the clinical evaluation assessment report (CEAR) for each device is uploaded in Eudamed prior to issuing the QMS certificate. This means that the sampling will not apply to the clinical evaluation as it has to be assessed for every device."

In our understanding of the underlined sentence, Article 54(3) and 55 do neither require an assessment for every product!  Article 54(3) just states that a notification has to be given, in case the consultation procedure has been applied. Article 55 states that the CA has to be informed about certificates granted on conformity assessments with the consultation procedure; which, in our understanding, do not replaces or overrules the sampling requirement of article 52 (4).

There for we cannot understand the conclusion, which has been written in the last sentence of that paragraph in MDCG 2019-13.

So far we did not get any clarification from our NB on that question, therefore I would like to put this question here in the forum.

Is this interpretation correct? Are there further requirements in the MDR that we overlook? Has anyone also experience on that questions with their NB? Has anyone some more background on the consultation procedure or the MDCG 2019-13?

Thanks a lot for any feedback or comment on this topic.

I have some questions to the interpretation and application of the consultation procedure according article 54 section1 for class IIb devices falling under rule 12. 

MDR Article 52 section 4 requires in general the manufacture of class IIb products to perform a conformity assessment acc. Annex IX Chapter I (QMS assessment) and assessment of the TD as section 4 of Annex IX for one representative device per generic device group. It also includes requirements for class IIb implantable devices.

MDR Article 54 section 1 require, that in addition to Article 52, a notified body shall perform the consultation procedure acc. Section 5.1 of Annex IX , when the NB is performing a conformity assessment.

So Article 54 section 1 contains explicitly an additional special condition "when performing a conformity assessment of the following devices: [..]". To our understanding this additional condition is very important and we assume it has been placed in the MDR very meaningful, as such conditions are not present in Article 52 section 9 and 10 when demanding special procedures according 5.2 or 5.3 of Annex IX.

 Our interpretation of Article 54 (1) in combination with Article 52 (4) for products of Class IIb falling under rule 12 is that the consultation procedure according 5.1 of Annex IX is only applicable as part of the sampling activities of the NB for evaluation of the technical documentation as it takes place for the first assessment and any further surveillance assessments.

We found as well in the MDCG guideline 2019-13, chapter 5.3 the following interpretation, which we cannot understand:

"According to Article 54, Class IIb active devices intended to administer and/or remove a medicinal product falling into rule 12 of Annex VIII are subject to the clinical evaluation consultation procedure prior to issuing of the certificate. These devices can be subject to sampling but according to Articles 54(3) and 55 the notified body must ensure that at least the clinical evaluation assessment report (CEAR) for each device is uploaded in Eudamed prior to issuing the QMS certificate. This means that the sampling will not apply to the clinical evaluation as it has to be assessed for every device."

In our understanding of the underlined sentence, Article 54(3) and 55 do neither require an assessment for every product!  Article 54(3) just states that a notification has to be given, in case the consultation procedure has been applied. Article 55 states that the CA has to be informed about certificates granted on conformity assessments with the consultation procedure; which, in our understanding, do not replaces or overrules the sampling requirement of article 52 (4).

There for we cannot understand the conclusion, which has been written in the last sentence of that paragraph in MDCG 2019-13.

So far we did not get any clarification from our NB on that question, therefore I would like to put this question here in the forum.

Is this interpretation correct? Are there further requirements in the MDR that we overlook? Has anyone also experience on that questions with their NB? Has anyone some more background on the consultation procedure or the MDCG 2019-13?

Thanks a lot for any feedback or comment on this topic.

This is the information that I have received from different notified bodies, TÜV SÜD, BSI, etc, as well as competent authorities: the text of the MDR, since it is a regulation, overrules MDCG as well as other guidances/ guidelines (which will be or have been issued). 

This means that the text of the MDR needs to be followed rather than that of the MDCG. Notified bodies as well as competent authorities have noted and are fully aware of the inconsistencies of the MDCG documents vs the MDR.

My recommendation to companies is if the MDCG guidance has sentence(s)/ text which are not alignment with the MDR, document these in your QMS system, and follow the text of the MDR.  

For your medical device Technical File submission, I recommend to make a proposal to the NB how you will address the MDR requirements. The proposal should be written in fashion that the NB can give a yes/no answer (since they are not allowed to consult).

The level of the quality of these MDCGs is reflected in the number which have now been revised, shortly following their release.  

Yes, I agree with the previous comments, it is a mess.

An interesting question to raise: Does the EU have a fully operational QMS system?

Best of luck.
It would be very interesting if you give us feedback on how things went.

Best Regards,
Stephanie

I have some questions to the interpretation and application of the consultation procedure according article 54 section1 for class IIb devices falling under rule 12. 

MDR Article 52 section 4 requires in general the manufacture of class IIb products to perform a conformity assessment acc. Annex IX Chapter I (QMS assessment) and assessment of the TD as section 4 of Annex IX for one representative device per generic device group. It also includes requirements for class IIb implantable devices.

MDR Article 54 section 1 require, that in addition to Article 52, a notified body shall perform the consultation procedure acc. Section 5.1 of Annex IX , when the NB is performing a conformity assessment.

So Article 54 section 1 contains explicitly an additional special condition "when performing a conformity assessment of the following devices: [..]". To our understanding this additional condition is very important and we assume it has been placed in the MDR very meaningful, as such conditions are not present in Article 52 section 9 and 10 when demanding special procedures according 5.2 or 5.3 of Annex IX.

 Our interpretation of Article 54 (1) in combination with Article 52 (4) for products of Class IIb falling under rule 12 is that the consultation procedure according 5.1 of Annex IX is only applicable as part of the sampling activities of the NB for evaluation of the technical documentation as it takes place for the first assessment and any further surveillance assessments.

We found as well in the MDCG guideline 2019-13, chapter 5.3 the following interpretation, which we cannot understand:

"According to Article 54, Class IIb active devices intended to administer and/or remove a medicinal product falling into rule 12 of Annex VIII are subject to the clinical evaluation consultation procedure prior to issuing of the certificate. These devices can be subject to sampling but according to Articles 54(3) and 55 the notified body must ensure that at least the clinical evaluation assessment report (CEAR) for each device is uploaded in Eudamed prior to issuing the QMS certificate. This means that the sampling will not apply to the clinical evaluation as it has to be assessed for every device."

In our understanding of the underlined sentence, Article 54(3) and 55 do neither require an assessment for every product!  Article 54(3) just states that a notification has to be given, in case the consultation procedure has been applied. Article 55 states that the CA has to be informed about certificates granted on conformity assessments with the consultation procedure; which, in our understanding, do not replaces or overrules the sampling requirement of article 52 (4).

There for we cannot understand the conclusion, which has been written in the last sentence of that paragraph in MDCG 2019-13.

So far we did not get any clarification from our NB on that question, therefore I would like to put this question here in the forum.

Is this interpretation correct? Are there further requirements in the MDR that we overlook? Has anyone also experience on that questions with their NB? Has anyone some more background on the consultation procedure or the MDCG 2019-13?

Thanks a lot for any feedback or comment on this topic.