Regulatory Open Forum

This is not related to the MDR, but results from the broken harmonization process in the EU. Many harmonized standards are obsolete, and have been for years. I don't see a resolution for a long time.

The MDD Annex I(2) says, "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art". One element in state of the art is the latest version of a standard. There is a good discussion of this in ISO 14971:2007.

When the harmonization process worked, the latest version of the standards were also the harmonized version. Harmonized standards provide a legal presumption of conformity, but the MDD does not require them. It does require state of the art.

This is not related to the MDR, but results from the broken harmonization process in the EU. Many harmonized standards are obsolete, and have been for years. I don't see a resolution for a long time.

The MDD Annex I(2) says, "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art". One element in state of the art is the latest version of a standard. There is a good discussion of this in ISO 14971:2007.

When the harmonization process worked, the latest version of the standards were also the harmonized version. Harmonized standards provide a legal presumption of conformity, but the MDD does not require them. It does require state of the art.

Your Notified Body (NB) appears to be applying what I've seen NBs deem as a most fundamental principle embodied in both the MDD and the MDR alike.  I've encountered this before, most recently earlier this year during an assessment by a prominent NB.

The first tenet of this principle is that compliance with the MDD Essential Requirements (ER) or, upon transition, the MDR General Safety and Performance Requirements (GSPR), is fundamentally paramount relative to the application of harmonized standards.  In other words, despite the pervasive use of harmonized standards, their application is, except regarding symbols in the labeling, only one possible means of demonstrating conformity with the ER / GSPR.  Note that this tenet is fundamentally the same in both the MDD (see preface paragraph 16 and Article 5) and the MDR (see preface item 22 and Article 8, among others).

The second tenet of this principle is driven by NB interpretations that compliance with the state of the art is one of the most important MDD ERs and MDR GSPRs.  Like the first tenet, this second tenet has been in place for decades and is fundamentally the same in both the MDD (e.g., see Annex I.I.2 first paragraph) and the MDR (e.g., see Annex I.I.1).

Therefore, in consideration of NB interpretations that ER / GSPR conformity (and thereby conformity with the state of the art) are paramount relative to application of harmonized standards, then it becomes easier to see why it can be argued that it is legislatively correct for an NB to push for compliance with the latest versions of applicable standards rather than the harmonized version.  Indeed, in these terms, harmonized standards are oftentimes no longer the state of the art – a phenomenon experienced time and again under the MDD, and that will continue under the MDR.

Finally, regarding NB mandates for complying with particular standards, take note that in actuality, such mandates are fundamentally contrary to the intent of the MDD and MDR.  Specifically, remember that the MDD and the MDR alike both maintain the liberty for manufacturers to adopt alternative conformity solutions if such alternatives ensure a level of safety and performance at least equivalent to the standard.  Examples of such liberty are MDD prefacing paragraph 16 plus Article 5, and MDR prefacing item 22 plus Article 9.3 (specifically in the context of common specifications), Article 71.3(b), and Annex XI.15.1.  Therefore, this provides valid grounds for questioning such NB mandates, and I have previously won such appeals accordingly.

Now, in defense of the NBs, verifying conformity with a known standard is logistically easier than verifying the integrity of a manufacturer's alternative conformity approach plus the resulting ER / GSPR conformity.  Consequently, such NB mandates are understandable, and are in fact quite common.  But when pushing back against such mandates, I've found that NBs will acknowledge and make way for the intended liberty provided by the MDD/MDR.  Yet remember that, in theory, standards are derived with input from consortia of our industry's most qualified members.  Therefore, attempting to derive an alternative conformity approach most certainly involves a lot of heaving lifting and swimming upstream against some very strong currents; thus the reason that most stakeholders in the end usually just opt to apply a known standard.

Your Notified Body (NB) appears to be applying what I've seen NBs deem as a most fundamental principle embodied in both the MDD and the MDR alike.  I've encountered this before, most recently earlier this year during an assessment by a prominent NB.

The first tenet of this principle is that compliance with the MDD Essential Requirements (ER) or, upon transition, the MDR General Safety and Performance Requirements (GSPR), is fundamentally paramount relative to the application of harmonized standards.  In other words, despite the pervasive use of harmonized standards, their application is, except regarding symbols in the labeling, only one possible means of demonstrating conformity with the ER / GSPR.  Note that this tenet is fundamentally the same in both the MDD (see preface paragraph 16 and Article 5) and the MDR (see preface item 22 and Article 8, among others).

The second tenet of this principle is driven by NB interpretations that compliance with the state of the art is one of the most important MDD ERs and MDR GSPRs.  Like the first tenet, this second tenet has been in place for decades and is fundamentally the same in both the MDD (e.g., see Annex I.I.2 first paragraph) and the MDR (e.g., see Annex I.I.1).

Therefore, in consideration of NB interpretations that ER / GSPR conformity (and thereby conformity with the state of the art) are paramount relative to application of harmonized standards, then it becomes easier to see why it can be argued that it is legislatively correct for an NB to push for compliance with the latest versions of applicable standards rather than the harmonized version.  Indeed, in these terms, harmonized standards are oftentimes no longer the state of the art – a phenomenon experienced time and again under the MDD, and that will continue under the MDR.

Finally, regarding NB mandates for complying with particular standards, take note that in actuality, such mandates are fundamentally contrary to the intent of the MDD and MDR.  Specifically, remember that the MDD and the MDR alike both maintain the liberty for manufacturers to adopt alternative conformity solutions if such alternatives ensure a level of safety and performance at least equivalent to the standard.  Examples of such liberty are MDD prefacing paragraph 16 plus Article 5, and MDR prefacing item 22 plus Article 9.3 (specifically in the context of common specifications), Article 71.3(b), and Annex XI.15.1.  Therefore, this provides valid grounds for questioning such NB mandates, and I have previously won such appeals accordingly.

Now, in defense of the NBs, verifying conformity with a known standard is logistically easier than verifying the integrity of a manufacturer's alternative conformity approach plus the resulting ER / GSPR conformity.  Consequently, such NB mandates are understandable, and are in fact quite common.  But when pushing back against such mandates, I've found that NBs will acknowledge and make way for the intended liberty provided by the MDD/MDR.  Yet remember that, in theory, standards are derived with input from consortia of our industry's most qualified members.  Therefore, attempting to derive an alternative conformity approach most certainly involves a lot of heaving lifting and swimming upstream against some very strong currents; thus the reason that most stakeholders in the end usually just opt to apply a known standard.

Your Notified Body (NB) appears to be applying what I've seen NBs deem as a most fundamental principle embodied in both the MDD and the MDR alike.  I've encountered this before, most recently earlier this year during an assessment by a prominent NB.

The first tenet of this principle is that compliance with the MDD Essential Requirements (ER) or, upon transition, the MDR General Safety and Performance Requirements (GSPR), is fundamentally paramount relative to the application of harmonized standards.  In other words, despite the pervasive use of harmonized standards, their application is, except regarding symbols in the labeling, only one possible means of demonstrating conformity with the ER / GSPR.  Note that this tenet is fundamentally the same in both the MDD (see preface paragraph 16 and Article 5) and the MDR (see preface item 22 and Article 8, among others).

The second tenet of this principle is driven by NB interpretations that compliance with the state of the art is one of the most important MDD ERs and MDR GSPRs.  Like the first tenet, this second tenet has been in place for decades and is fundamentally the same in both the MDD (e.g., see Annex I.I.2 first paragraph) and the MDR (e.g., see Annex I.I.1).

Therefore, in consideration of NB interpretations that ER / GSPR conformity (and thereby conformity with the state of the art) are paramount relative to application of harmonized standards, then it becomes easier to see why it can be argued that it is legislatively correct for an NB to push for compliance with the latest versions of applicable standards rather than the harmonized version.  Indeed, in these terms, harmonized standards are oftentimes no longer the state of the art – a phenomenon experienced time and again under the MDD, and that will continue under the MDR.

Finally, regarding NB mandates for complying with particular standards, take note that in actuality, such mandates are fundamentally contrary to the intent of the MDD and MDR.  Specifically, remember that the MDD and the MDR alike both maintain the liberty for manufacturers to adopt alternative conformity solutions if such alternatives ensure a level of safety and performance at least equivalent to the standard.  Examples of such liberty are MDD prefacing paragraph 16 plus Article 5, and MDR prefacing item 22 plus Article 9.3 (specifically in the context of common specifications), Article 71.3(b), and Annex XI.15.1.  Therefore, this provides valid grounds for questioning such NB mandates, and I have previously won such appeals accordingly.

Now, in defense of the NBs, verifying conformity with a known standard is logistically easier than verifying the integrity of a manufacturer's alternative conformity approach plus the resulting ER / GSPR conformity.  Consequently, such NB mandates are understandable, and are in fact quite common.  But when pushing back against such mandates, I've found that NBs will acknowledge and make way for the intended liberty provided by the MDD/MDR.  Yet remember that, in theory, standards are derived with input from consortia of our industry's most qualified members.  Therefore, attempting to derive an alternative conformity approach most certainly involves a lot of heaving lifting and swimming upstream against some very strong currents; thus the reason that most stakeholders in the end usually just opt to apply a known standard.