Regulatory Open Forum

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

I looked at MDCG 2021-08 Clinical investigation application/notification documents dated May 2021. It has only four pages, so I didn't find your reference to page 5. However, it does contain another document titled Checklist of general safety and performance requirements, Standards, common specifications, and scientific advice.

This is in two parts one is a list of the "Standards, common specifications, scientific advice obtained from expert panels according to article 106 MDR". The other is a GS&PR checklist which asks for a list of "Standards and common specifications used in full or in part" and "Justification/ comment in case of deviation"

In other words, you don't justify using a particular standard or common specification. Rather, justify deviations from the standard or common specification used.

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

I looked at MDCG 2021-08 Clinical investigation application/notification documents dated May 2021. It has only four pages, so I didn't find your reference to page 5. However, it does contain another document titled Checklist of general safety and performance requirements, Standards, common specifications, and scientific advice.

This is in two parts one is a list of the "Standards, common specifications, scientific advice obtained from expert panels according to article 106 MDR". The other is a GS&PR checklist which asks for a list of "Standards and common specifications used in full or in part" and "Justification/ comment in case of deviation"

In other words, you don't justify using a particular standard or common specification. Rather, justify deviations from the standard or common specification used.

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

I looked at MDCG 2021-08 Clinical investigation application/notification documents dated May 2021. It has only four pages, so I didn't find your reference to page 5. However, it does contain another document titled Checklist of general safety and performance requirements, Standards, common specifications, and scientific advice.

This is in two parts one is a list of the "Standards, common specifications, scientific advice obtained from expert panels according to article 106 MDR". The other is a GS&PR checklist which asks for a list of "Standards and common specifications used in full or in part" and "Justification/ comment in case of deviation"

In other words, you don't justify using a particular standard or common specification. Rather, justify deviations from the standard or common specification used.

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

I looked at MDCG 2021-08 Clinical investigation application/notification documents dated May 2021. It has only four pages, so I didn't find your reference to page 5. However, it does contain another document titled Checklist of general safety and performance requirements, Standards, common specifications, and scientific advice.

This is in two parts one is a list of the "Standards, common specifications, scientific advice obtained from expert panels according to article 106 MDR". The other is a GS&PR checklist which asks for a list of "Standards and common specifications used in full or in part" and "Justification/ comment in case of deviation"

In other words, you don't justify using a particular standard or common specification. Rather, justify deviations from the standard or common specification used.

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

I looked at MDCG 2021-08 Clinical investigation application/notification documents dated May 2021. It has only four pages, so I didn't find your reference to page 5. However, it does contain another document titled Checklist of general safety and performance requirements, Standards, common specifications, and scientific advice.

This is in two parts one is a list of the "Standards, common specifications, scientific advice obtained from expert panels according to article 106 MDR". The other is a GS&PR checklist which asks for a list of "Standards and common specifications used in full or in part" and "Justification/ comment in case of deviation"

In other words, you don't justify using a particular standard or common specification. Rather, justify deviations from the standard or common specification used.

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?

I looked at MDCG 2021-08 Clinical investigation application/notification documents dated May 2021. It has only four pages, so I didn't find your reference to page 5. However, it does contain another document titled Checklist of general safety and performance requirements, Standards, common specifications, and scientific advice.

This is in two parts one is a list of the "Standards, common specifications, scientific advice obtained from expert panels according to article 106 MDR". The other is a GS&PR checklist which asks for a list of "Standards and common specifications used in full or in part" and "Justification/ comment in case of deviation"

In other words, you don't justify using a particular standard or common specification. Rather, justify deviations from the standard or common specification used.

HERESY ALERT At this point, whether a standard is harmonized is of no value. It is more important to use the most recent EN standard including any amendments.

For GS&PR, use the most recent applicable standard. Give preference to EN standards over international standards when they have the same technical content. The list of standards on the CEN/CENELEC website lists the corresponding international standard.

If the current version of an international standard is ahead of the EN standard, use the international standard as state of the art. At some point, the EN standard will catch up.

You need to cite the standard you actually used. If it is not the latest, i.e., not state of the art, then you need a plan to implement the latest one. A similar situation applies if the standard changes.

You need to cite the standard correctly, including all amendments. For example, you should be using and citing EN ISO 14971:2019/A11:2021. By convention, for EN standards, people don't include the standards body that published the standard. You could cite, instead EVS-EN ISO 14971:2019/A11:2021.

For any standard used, note whether it is harmonized. You cannot tell from the citation.

You say, "As per EUMDR, qualification of each standard is required". I don't understand the remark. Could you provide more information?