Regulatory Open Forum

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Hi Britta,

It depends on the description of the device. If you can take accurate information directly from a patient, then it is ok.
For some devices, the patient cannot provide the necessary information, thus you can extract the required information through the professional user, which will gather the data from examination and from the patient.
But in both cases, the information will derived from the patient.

This is my view on this article.
Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

My personal view is it may include both.  When talking about population using the device this means the healthcare professional, but from a risk perspective this also includes the patient.  When we write Technical Documentation content regarding device description this includes patient population - the actual person device is used on, the mode of action - how the device is used with or on the patient, use condition - who actually uses the device like a physician including where the device is used such as in surgery or ER situation.  Under the EU MDR, when thinking about population using the device, you should be thinking about the overall device and lifecycle of the device, not just trying to answer specific questions.  When looking at the EU MDR, while there may be "a requirement" this might need to be answered with 3 or 4 pieces of information.

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

Original Message:
Sent: 04-Mar-2020 04:23
From: Spyros Drivelos
Subject: Article 86 MDR (PSUR)

Hi Britta,

It depends on the description of the device. If you can take accurate information directly from a patient, then it is ok.
For some devices, the patient cannot provide the necessary information, thus you can extract the required information through the professional user, which will gather the data from examination and from the patient.
But in both cases, the information will derived from the patient.

This is my view on this article.
Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Spyros and Richard,
Thank you for your insights! This helps to find our path in the jungle called MDR :-)

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Original Message:
Sent: 04-Mar-2020 09:19
From: Richard Vincins
Subject: Article 86 MDR (PSUR)

My personal view is it may include both.  When talking about population using the device this means the healthcare professional, but from a risk perspective this also includes the patient.  When we write Technical Documentation content regarding device description this includes patient population - the actual person device is used on, the mode of action - how the device is used with or on the patient, use condition - who actually uses the device like a physician including where the device is used such as in surgery or ER situation.  Under the EU MDR, when thinking about population using the device, you should be thinking about the overall device and lifecycle of the device, not just trying to answer specific questions.  When looking at the EU MDR, while there may be "a requirement" this might need to be answered with 3 or 4 pieces of information.

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

Original Message:
Sent: 04-Mar-2020 04:23
From: Spyros Drivelos
Subject: Article 86 MDR (PSUR)

Hi Britta,

It depends on the description of the device. If you can take accurate information directly from a patient, then it is ok.
For some devices, the patient cannot provide the necessary information, thus you can extract the required information through the professional user, which will gather the data from examination and from the patient.
But in both cases, the information will derived from the patient.

This is my view on this article.
Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Hi all
The company should also be in line with standard  EN 62366-1, -2 Usability Enginnering, where the manufacturer should describe and determine the user profile, patient profile and environmental profile. So even this standard can help you if you already have a Usability report in PSUR

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

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Agree with all above contribution and I would like to add that the intended purpose of a medical device can only be clear when also the intended use environment and the intended users (patient, health care providers) ​ during the lifecycle of the device are known. In my opinion this even can include safety aspects for intended users during service and decommissioning.

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

Original Message:
Sent: 05-Mar-2020 01:49
From: Evangelos Tavandzis
Subject: Article 86 MDR (PSUR)

Hi all
The company should also be in line with standard  EN 62366-1, -2 Usability Enginnering, where the manufacturer should describe and determine the user profile, patient profile and environmental profile. So even this standard can help you if you already have a Usability report in PSUR

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

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Hi everyone,
Looking at the answers, are we expanding the term Population into the people whoever is using or handling the device? right from transportation till decommissioning??

------------------------------
Kamal Solomon
Gurgaon
India
------------------------------

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Well, yes; in risk management ​all the risks associated with the medical device, including usability aspects, during its lifetime are addressed and in the PSUR the feedback on safety is discussed. From that perspective risks associated with all 'users' should be addressed in the PMS plan and PSUR. The use of suitable thresholds can avoid discussing the nitty gritty details.

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

Original Message:
Sent: 05-Mar-2020 04:45
From: Kamal Solomon
Subject: Article 86 MDR (PSUR)

Hi everyone,
Looking at the answers, are we expanding the term Population into the people whoever is using or handling the device? right from transportation till decommissioning??

------------------------------
Kamal Solomon
Gurgaon
India

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Hi Peter,

Since you mentioned thresholds, I am looking to have PSUR template ready for low-risk devices with no history of serious incidents and no thresholds defined before for identified risks.

Is there a guideline to determine the suitable thresholds? With almost zero complaints, I am having difficulty to define the thresholds.

--------------------------
Saqib Tanweer
Toronto,
Canada
------------------------

------------------------------
Saqib Tanweer
Unit 1 ON
Canada
------------------------------

Original Message:
Sent: 06-Mar-2020 04:11
From: Peter Reijntjes
Subject: Article 86 MDR (PSUR)

Well, yes; in risk management ​all the risks associated with the medical device, including usability aspects, during its lifetime are addressed and in the PSUR the feedback on safety is discussed. From that perspective risks associated with all 'users' should be addressed in the PMS plan and PSUR. The use of suitable thresholds can avoid discussing the nitty gritty details.

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

Original Message:
Sent: 05-Mar-2020 04:45
From: Kamal Solomon
Subject: Article 86 MDR (PSUR)

Hi everyone,
Looking at the answers, are we expanding the term Population into the people whoever is using or handling the device? right from transportation till decommissioning??

------------------------------
Kamal Solomon
Gurgaon
India

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Great feedback. I interpret it as both patient and clinician. Also agree with the holistic approach. My company offers several home care devices where the patient and user are synonymous.

------------------------------
Rob Yamashita
Grand Rapids MI
United States
------------------------------

Original Message:
Sent: 03-Mar-2020 05:34
From: Britta Cyron
Subject: Article 86 MDR (PSUR)

Hi all,
we had a discussion regarding paragraph c of article 86 MDR (PSUR) regarding "the population using the device"...
Our devices are not used by the patients themselves, they are used on the patient by a physician.
Which group should we discuss in the PSUR? Patients or physicians? The german text is more clear on the subject, ("Personen, bei denen das betreffende Produkt zur Anwendung kommt" -> patients), but my colleagues are unsure whether the german text is accurate.

Thank you for your insights!

------------------------------
Britta Cyron
Bochum
Germany
------------------------------