Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

EU Commission, but good luck with trying to get meaningful information from them too.  You should raise the questions to the Competent Authority up to including their reasoning behind the interpretation.  Unfortunately, there are and can be varied interpretations of regulations even when it seems quite clear to you.  It also might be interesting to post the situation in this forum to get some comments and feedback.

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

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

Thank you for your comments.

I decided to get a second opinion on the question I placed on one competent authority.

Which competent authority is right CA1 or CA2?
As far as I have found out the anti-snoring devices are medical devices all over the world.

CA 1:
Sehr geehrte …,
vielen Dank für Ihre Anfrage.
Nach unserer Einschätzung ist eine Anti-Schnarch-Schiene als Medizinprodukt der Klasse I einzustufen. Eine Recherche im Medizinprodukte-Informationssystem von DIMDI, in dem die in Deutschland auf den Markt gebrachten Medizinprodukte registriert werden, bestätigt dies.

(In our opinion, an anti-snoring device should be classified as a class I medical device. This is confirmed by research in the DIMDI medical device information system, in which the medical devices put on the market in Germany are registered.)


CA2:
Hei!
Kuorsaus ei itsessään ole sairaus joten kuorsaukseen tarkoitetut tuotteet eivät ole lääkinnällisiä laitteita. Kuluttajatuotteiden valvonta kuuluu Tukesille.

(Snoring is not a disease in itself, so snoring products are not medical devices. Supervision of consumer products is the responsibility of Tukes.)


I included this description to my request:
A short description of snoring and anti-snoring devices

The type of anti-snoring device in question is an intraoral mandible advancement device, mandibular re-positioner, that is placed in between teeth and it keeps the jaw in a protruded position during sleep and thus alters the anatomy.

Snoring results from airflow-induced flutter of soft tissues of the nasopharynx, particularly the soft palate. As in any fluttering physical structure (eg, a flag), flutter in the nasopharynx develops depending on interacting factors, including the mass, stiffness, and attachments of the fluttering element and the velocity and direction of airflow. The fact that people do not snore while awake suggests that sleep-induced muscular relaxation is at least part of the etiology because muscle tone is the only component of flutter that can change during sleep; tissue mass and attachments do not change. Furthermore, if pharyngeal dilators cannot keep the airway open in response to the negative intraluminal pressure induced by inspiration, the upper airway narrows, increasing local airflow velocity (for a given inspiratory volume). The increased flow velocity promotes flutter directly and decreases intraluminal pressure, further enhancing airway closure and thus promoting flutter and noise, snoring.

The flutter, tissue vibration, causes damage to the muscles and nerves surrounding the airway and leads to lost patency and restriction of the airflow and may lead to a total collapse of the airway, obstructive sleep apnea.

Mandibular advancement devices, called also anti-snoring devices, oral -appliances, mandibular advancement splints, etc. alter the physiology by moving the jaw forward thus moving the tongue forward to open the airway during sleep. They enlarge and stabilize the oro- and hypo-pharyngeal airway space by advancing the mandible, and stretching the attached soft tissue, in particular, the tongue, soft palate, uvula, and the pharyngeal tissues and thus reduces the vibration of the soft tissues in the upper airway.

So, the intended purpose of an antisnoring device is treatment and alleviation of snoring and it modifies the anatomy for this purpose as described above.


Original Message:
Sent: 14-Jan-2020 02:50
From: Richard Vincins
Subject: Incompetence of Competent Authority

EU Commission, but good luck with trying to get meaningful information from them too.  You should raise the questions to the Competent Authority up to including their reasoning behind the interpretation.  Unfortunately, there are and can be varied interpretations of regulations even when it seems quite clear to you.  It also might be interesting to post the situation in this forum to get some comments and feedback.

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

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

Ok, now we're getting somewhere. 

I will assume you are referring to "a medical device" as defined by the MDR.  This is the first thing it is helpful to understand.  There is no such thing as "a medical device," except in concept.  Whether or not a particular device or type of device is "a medical device" in the real world depends entirely on who is defining the term and what definition they use.  So forget about "all over the world."

Things get more complicated when those who came up with the definition are not the ones who decide whether a particular device or type of device meets the definition.  If it is the MDR, then your CA did not come up with this definition.  Might not even agree with it.

I'm not familiar with EU law, nor the laws of individual European countries, but Ludger's mention of the courts suggests it might not be all that different than in the US, where the only authority that could ultimately decide this is the courts.  And it would be the "ultimate" decision only if the parties worked through the entire process, including any options for appeals.  And, even then, it would be the ultimate decision until it wasn't any more.

I think the definition that is hanging you up is not so much the definition of "medical device," but of "medical purpose."  The experts in all things "medical" are not politicians or device companies, but MDs.  I think many MDs would tell you that snoring is not a medical condition.  However, snoring can, over time, lead to sleep apnea (you seem to be mixing the two), which is a medical condition.  If so, it's for prevention, not treatment.  If that's the case, and your claim is that it treats snoring, rather than preventing sleep apnea, that might be the crux of the problem.

If you want a persuasive argument on "medical purpose," then you need to consult a medical professional.  If you want to know how to make a persuasive argument to a regulatory body and how to craft appropriate claims for a regulated product, then you need to consult a (pretty experienced) regulatory professional.  If your employer won't spend the money to avail itself of the expertise that is needed to be a medical device company, keep your eye out for a new employer.  In this case, you might still be able to convince the CA otherwise, with the right expertise.  But usually it is much easier to persuade regulators up front than it is to get them to change their minds later.

------------------------------
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: 26-Jan-2020 06:02
From: Pertti Vaisanen
Subject: Incompetence of Competent Authority

Thank you for your comments.

I decided to get a second opinion on the question I placed on one competent authority.

Which competent authority is right CA1 or CA2?
As far as I have found out the anti-snoring devices are medical devices all over the world.

CA 1:
Sehr geehrte …,
vielen Dank für Ihre Anfrage.
Nach unserer Einschätzung ist eine Anti-Schnarch-Schiene als Medizinprodukt der Klasse I einzustufen. Eine Recherche im Medizinprodukte-Informationssystem von DIMDI, in dem die in Deutschland auf den Markt gebrachten Medizinprodukte registriert werden, bestätigt dies.

(In our opinion, an anti-snoring device should be classified as a class I medical device. This is confirmed by research in the DIMDI medical device information system, in which the medical devices put on the market in Germany are registered.)


CA2:
Hei!
Kuorsaus ei itsessään ole sairaus joten kuorsaukseen tarkoitetut tuotteet eivät ole lääkinnällisiä laitteita. Kuluttajatuotteiden valvonta kuuluu Tukesille.

(Snoring is not a disease in itself, so snoring products are not medical devices. Supervision of consumer products is the responsibility of Tukes.)


I included this description to my request:
A short description of snoring and anti-snoring devices

The type of anti-snoring device in question is an intraoral mandible advancement device, mandibular re-positioner, that is placed in between teeth and it keeps the jaw in a protruded position during sleep and thus alters the anatomy.

Snoring results from airflow-induced flutter of soft tissues of the nasopharynx, particularly the soft palate. As in any fluttering physical structure (eg, a flag), flutter in the nasopharynx develops depending on interacting factors, including the mass, stiffness, and attachments of the fluttering element and the velocity and direction of airflow. The fact that people do not snore while awake suggests that sleep-induced muscular relaxation is at least part of the etiology because muscle tone is the only component of flutter that can change during sleep; tissue mass and attachments do not change. Furthermore, if pharyngeal dilators cannot keep the airway open in response to the negative intraluminal pressure induced by inspiration, the upper airway narrows, increasing local airflow velocity (for a given inspiratory volume). The increased flow velocity promotes flutter directly and decreases intraluminal pressure, further enhancing airway closure and thus promoting flutter and noise, snoring.

The flutter, tissue vibration, causes damage to the muscles and nerves surrounding the airway and leads to lost patency and restriction of the airflow and may lead to a total collapse of the airway, obstructive sleep apnea.

Mandibular advancement devices, called also anti-snoring devices, oral -appliances, mandibular advancement splints, etc. alter the physiology by moving the jaw forward thus moving the tongue forward to open the airway during sleep. They enlarge and stabilize the oro- and hypo-pharyngeal airway space by advancing the mandible, and stretching the attached soft tissue, in particular, the tongue, soft palate, uvula, and the pharyngeal tissues and thus reduces the vibration of the soft tissues in the upper airway.

So, the intended purpose of an antisnoring device is treatment and alleviation of snoring and it modifies the anatomy for this purpose as described above.


Original Message:
Sent: 14-Jan-2020 02:50
From: Richard Vincins
Subject: Incompetence of Competent Authority

EU Commission, but good luck with trying to get meaningful information from them too.  You should raise the questions to the Competent Authority up to including their reasoning behind the interpretation.  Unfortunately, there are and can be varied interpretations of regulations even when it seems quite clear to you.  It also might be interesting to post the situation in this forum to get some comments and feedback.

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

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

It is not clear at all to whom you are referring. A competent authority refers to the agency within a country charged with enforcing regulations. So for the EU, it depends on the country with which you are specifically dealing. I would question if you are dealing with a competent authority or the notified body. Please clarify and then perhaps the community can help.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

Or possibly it's one hair-raisingly incompetent employee within a competent authority / regulatory agency (or within a notified body)? 
In that case, there are ways to contact supervisors or file appeals, depending on the type of problem.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 14-Jan-2020 06:16
From: Mark Swanson
Subject: Incompetence of Competent Authority

It is not clear at all to whom you are referring. A competent authority refers to the agency within a country charged with enforcing regulations. So for the EU, it depends on the country with which you are specifically dealing. I would question if you are dealing with a competent authority or the notified body. Please clarify and then perhaps the community can help.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

I feel forced to observe that not understanding the regulatory framework in a jurisdiction in which you are, or are planning to, market a medical device is not a promising sign...

------------------------------
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: 14-Jan-2020 06:16
From: Mark Swanson
Subject: Incompetence of Competent Authority

It is not clear at all to whom you are referring. A competent authority refers to the agency within a country charged with enforcing regulations. So for the EU, it depends on the country with which you are specifically dealing. I would question if you are dealing with a competent authority or the notified body. Please clarify and then perhaps the community can help.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

Thank you for your comments.

I decided to get a second opinion on the question I placed on one competent authority.

Which competent authority is right CA1 or CA2?
As far as I have found out the anti-snoring devices are medical devices all over the world.

CA 1:
Sehr geehrte …,
vielen Dank für Ihre Anfrage.
Nach unserer Einschätzung ist eine Anti-Schnarch-Schiene als Medizinprodukt der Klasse I einzustufen. Eine Recherche im Medizinprodukte-Informationssystem von DIMDI, in dem die in Deutschland auf den Markt gebrachten Medizinprodukte registriert werden, bestätigt dies.

(In our opinion, an anti-snoring device should be classified as a class I medical device. This is confirmed by research in the DIMDI medical device information system, in which the medical devices put on the market in Germany are registered.)


CA2:
Hei!
Kuorsaus ei itsessään ole sairaus joten kuorsaukseen tarkoitetut tuotteet eivät ole lääkinnällisiä laitteita. Kuluttajatuotteiden valvonta kuuluu Tukesille.

(Snoring is not a disease in itself, so snoring products are not medical devices. Supervision of consumer products is the responsibility of Tukes.)


I included this description to my request:
A short description of snoring and anti-snoring devices

The type of anti-snoring device in question is an intraoral mandible advancement device, mandibular re-positioner, that is placed in between teeth and it keeps the jaw in a protruded position during sleep and thus alters the anatomy.

Snoring results from airflow-induced flutter of soft tissues of the nasopharynx, particularly the soft palate. As in any fluttering physical structure (eg, a flag), flutter in the nasopharynx develops depending on interacting factors, including the mass, stiffness, and attachments of the fluttering element and the velocity and direction of airflow. The fact that people do not snore while awake suggests that sleep-induced muscular relaxation is at least part of the etiology because muscle tone is the only component of flutter that can change during sleep; tissue mass and attachments do not change. Furthermore, if pharyngeal dilators cannot keep the airway open in response to the negative intraluminal pressure induced by inspiration, the upper airway narrows, increasing local airflow velocity (for a given inspiratory volume). The increased flow velocity promotes flutter directly and decreases intraluminal pressure, further enhancing airway closure and thus promoting flutter and noise, snoring.

The flutter, tissue vibration, causes damage to the muscles and nerves surrounding the airway and leads to lost patency and restriction of the airflow and may lead to a total collapse of the airway, obstructive sleep apnea.

Mandibular advancement devices, called also anti-snoring devices, oral -appliances, mandibular advancement splints, etc. alter the physiology by moving the jaw forward thus moving the tongue forward to open the airway during sleep. They enlarge and stabilize the oro- and hypo-pharyngeal airway space by advancing the mandible, and stretching the attached soft tissue, in particular, the tongue, soft palate, uvula, and the pharyngeal tissues and thus reduces the vibration of the soft tissues in the upper airway.

So, the intended purpose of an antisnoring device is treatment and alleviation of snoring and it modifies the anatomy for this purpose as described above.

------------------------------
Pertti Vaisanen
Tallinn
Estonia
------------------------------

Original Message:
Sent: 14-Jan-2020 17:13
From: Julie Omohundro
Subject: Incompetence of Competent Authority

I feel forced to observe that not understanding the regulatory framework in a jurisdiction in which you are, or are planning to, market a medical device is not a promising sign...

------------------------------
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: 14-Jan-2020 06:16
From: Mark Swanson
Subject: Incompetence of Competent Authority

It is not clear at all to whom you are referring. A competent authority refers to the agency within a country charged with enforcing regulations. So for the EU, it depends on the country with which you are specifically dealing. I would question if you are dealing with a competent authority or the notified body. Please clarify and then perhaps the community can help.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

To be a medical device then your labelling / intended use (and of course clinical benefit) need to have a medical claim.

2 questions then: Is snoring a disease? I am not convinced (and maybe the CA neither) but I am not a doctor so this is worth discussing with a generalist and providing the CA the clinical evidence (plus data from competitor). However could your device treat the sleep apnea which is caused / induced by some category of snoring? If yes, sleep apnea is a medical condition to be treated and you could convince them that your product is a medical device. But then in this case, you need to have the clinical data to demonstrate that you device support this clinical benefit and not only the snoring (or justify for any evident impact of snoring on the above).

That would be my route if I had this issue. Or go through the LVD, EMC, ... CE marking process if no medical claim.

------------------------------
Maud Giorgi
QMS & RA Manager
Lausanne
Switzerland
------------------------------

Original Message:
Sent: 26-Jan-2020 06:05
From: Pertti Vaisanen
Subject: Incompetence of Competent Authority

Thank you for your comments.

I decided to get a second opinion on the question I placed on one competent authority.

Which competent authority is right CA1 or CA2?
As far as I have found out the anti-snoring devices are medical devices all over the world.

CA 1:
Sehr geehrte …,
vielen Dank für Ihre Anfrage.
Nach unserer Einschätzung ist eine Anti-Schnarch-Schiene als Medizinprodukt der Klasse I einzustufen. Eine Recherche im Medizinprodukte-Informationssystem von DIMDI, in dem die in Deutschland auf den Markt gebrachten Medizinprodukte registriert werden, bestätigt dies.

(In our opinion, an anti-snoring device should be classified as a class I medical device. This is confirmed by research in the DIMDI medical device information system, in which the medical devices put on the market in Germany are registered.)


CA2:
Hei!
Kuorsaus ei itsessään ole sairaus joten kuorsaukseen tarkoitetut tuotteet eivät ole lääkinnällisiä laitteita. Kuluttajatuotteiden valvonta kuuluu Tukesille.

(Snoring is not a disease in itself, so snoring products are not medical devices. Supervision of consumer products is the responsibility of Tukes.)


I included this description to my request:
A short description of snoring and anti-snoring devices

The type of anti-snoring device in question is an intraoral mandible advancement device, mandibular re-positioner, that is placed in between teeth and it keeps the jaw in a protruded position during sleep and thus alters the anatomy.

Snoring results from airflow-induced flutter of soft tissues of the nasopharynx, particularly the soft palate. As in any fluttering physical structure (eg, a flag), flutter in the nasopharynx develops depending on interacting factors, including the mass, stiffness, and attachments of the fluttering element and the velocity and direction of airflow. The fact that people do not snore while awake suggests that sleep-induced muscular relaxation is at least part of the etiology because muscle tone is the only component of flutter that can change during sleep; tissue mass and attachments do not change. Furthermore, if pharyngeal dilators cannot keep the airway open in response to the negative intraluminal pressure induced by inspiration, the upper airway narrows, increasing local airflow velocity (for a given inspiratory volume). The increased flow velocity promotes flutter directly and decreases intraluminal pressure, further enhancing airway closure and thus promoting flutter and noise, snoring.

The flutter, tissue vibration, causes damage to the muscles and nerves surrounding the airway and leads to lost patency and restriction of the airflow and may lead to a total collapse of the airway, obstructive sleep apnea.

Mandibular advancement devices, called also anti-snoring devices, oral -appliances, mandibular advancement splints, etc. alter the physiology by moving the jaw forward thus moving the tongue forward to open the airway during sleep. They enlarge and stabilize the oro- and hypo-pharyngeal airway space by advancing the mandible, and stretching the attached soft tissue, in particular, the tongue, soft palate, uvula, and the pharyngeal tissues and thus reduces the vibration of the soft tissues in the upper airway.

So, the intended purpose of an antisnoring device is treatment and alleviation of snoring and it modifies the anatomy for this purpose as described above.

------------------------------
Pertti Vaisanen
Tallinn
Estonia

Original Message:
Sent: 14-Jan-2020 17:13
From: Julie Omohundro
Subject: Incompetence of Competent Authority

I feel forced to observe that not understanding the regulatory framework in a jurisdiction in which you are, or are planning to, market a medical device is not a promising sign...

------------------------------
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: 14-Jan-2020 06:16
From: Mark Swanson
Subject: Incompetence of Competent Authority

It is not clear at all to whom you are referring. A competent authority refers to the agency within a country charged with enforcing regulations. So for the EU, it depends on the country with which you are specifically dealing. I would question if you are dealing with a competent authority or the notified body. Please clarify and then perhaps the community can help.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

You will control the CA.  There is always the option to test any governmental decision in court.  It already has been successfully tested in regards to the MDR.  However, you may also see another outcome!

------------------------------
Ludger Moeller
President, MDSS GmbH
lmoeller@mdss.com
------------------------------

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?

Both responses sound logical to me, based on the limited information provided. One seems to take the device as described, as a ​sound modifier. The other says look, there are similar things used as OSA treatments.

So what does snoring mean? Is it a flag for physiological distress, or just one of many breath sounds? It may depend on what your product is really meant for, what it really accomplishes, what your documentation says it accomplishes, and what your customers will think the intended use is.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 14-Jan-2020 23:21
From: Ludger Moeller
Subject: Incompetence of Competent Authority

You will control the CA.  There is always the option to test any governmental decision in court.  It already has been successfully tested in regards to the MDR.  However, you may also see another outcome!

------------------------------
Ludger Moeller
President, MDSS GmbH
lmoeller@mdss.com

Original Message:
Sent: 13-Jan-2020 01:31
From: Anonymous Member
Subject: Incompetence of Competent Authority

This message was posted by a user wishing to remain anonymous

Who controls the Competent Authorities in the EU? Who to contact when the staff gives hair raising interpretations of MDD and MDR?