Regulatory Affairs And Its Applications (Medical Devices) at University Of Basel | Flashcards & Summaries

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Lernmaterialien für Regulatory Affairs and its Applications (Medical Devices) an der University of Basel

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What is the intended purpose?

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Intended Purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation (MDR, Article 2)

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What is a medical device?

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Article 2, MDR 2017/745

'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific purposes: 

  • diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, 
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, 

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following shall also be deemed to be medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and those referred in the first paragraph of this point (NOTE: refer also to Annex XVI of MDR)
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what is an in vitro diagnostic medical device?

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Article 2, IVDR 2017/746

'in vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

  1. concerning a physiological or pathological process or state;
  2. concerning congenital physical or mental impairments;
  3. concerning the predisposition to a medical condition or a disease;
  4. to determine the safety and compatibility with potential recipients;
  5. to predict treatment response or reactions;
  6. to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

This regulation does not apply to:

  1. products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
  2. invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
  3. internationally certified reference materials;
  4. materials used for external quality assessment schemes.


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What is DiGA / DGV / DiGAV?

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DiGA (Digitale Gesundheitsanwendungen / Apps on prescription)
DGV (Digitale-Versorgung-Gesetz)
DiGAV (Digitale Gesundheitsanwendung Verordnung)

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DGV / DiGAV: some facts

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  • DGV introduced the “app on prescription” in December 2019.
  • Persons covered by the German statutory health insurance are entitled to use a DiGA
    prescribed by a physician or psychotherapist and are reimbursed by the health insurance.
  • Prerequisite is that a DiGA must have successfully completed the assessment of the
    BfArM leading to a listing in the DiGA directory.
  • The process for the listing is defined in the DiGAV.
  • Costs for listing of device: EUR 3’000 – 9’900 (+ advice by BfArM EUR 250-5000)
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DiGA – Required properties

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A DiGA is a “digital assistant in the hands of the patient”.
CE-marked medical device that has the following properties:

  • Medical device of the risk class I or IIa (according to the Medical Device Regulation (MDR)
  • The main function of the DiGA is based on digital technologies. The medical purpose is mainly achieved by way of its digital function.
  • The DiGA supports the recognition, monitoring, treatment or alleviation of diseases or the recognition, treatment, alleviation or compensation of injuries or disabilities. It does not service primary prevention and it does not serve only for the collection of data from a device or for controlling a device.
  • The DiGA is used by the patient alone or by patient and healthcare provider together.
  • A DiGA can also comprise devices, sensors or other hardware in addition to software, such as wearables, as long as the main function is a predominantly digital one (needs to be evaluated case-specific)
  • A DiGA can also comprise services (however, positive healthcare has to be proven without considering the service (needs to be evaluated case-specific)
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DiGAV – Development Requirements (1/2)

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  • Requirements for data protection & information security
    • as of 1.1.2022 ISO 27001 certification is required!
  • Requirements for interoperatibility
    • should enable the continuous flow of information between all those involved in the healthcare system and their IT systems
    • Preferably MIO or vesta standards
  • Further quality requirements (robustness, user friendliness, functionality)
    • No data loss due to i.e. power supply failure
    • Easy to use
  • Checklists are provided by BfArM (Appendix 1 and 2 of DiGAV)
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DiGAV – Development Requirements (2/2)

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  • Evidence of positive healthcare effect (!)
    • Legal Manufacturer must prove that the use of the device is better than not using it
    • In this context, non-use means that a patient may be treated (comparison group)
      • with something else, or
      • not treated at all, or
      • with a comparable and already listed DiGA.
    • The choice comparison group must be oriented on the current practice.
  • (Clinical) Study in Germany is required and full results must be published


It is possible to get feedback from BfArM regarding DIGA:
https://www.bfarm.de/DE/BfArM/OrganisationAufgaben/Beratungsverfahren/Innovationsbue
ro/_node.html

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Classification: in accordance to what?

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MDR: Classification is carried out in accordance with Annex VIII of Regulation 2017/745


IVDR: Classification is carried out in accordance with Annex VIII of Regulation 2017/746

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Examples of Class I MDR

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  • Wheelchair
  • Otoscope
  • Hospital Beds
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Examples for MDR Class I* 

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  • Sterile Products (Is) 
  • Products with measuring function (Im)
  • Reprocessable surgical instruments (Ir)
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What is regulatory affairs?

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Profession developed by governments to protect public health by controlling the safety and efficacy of products

"It's the law"

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  • 48750 Karteikarten
  • 1019 Studierende
  • 37 Lernmaterialien

Beispielhafte Karteikarten für deinen Regulatory Affairs and its Applications (Medical Devices) Kurs an der University of Basel - von Kommilitonen auf StudySmarter erstellt!

Q:

What is the intended purpose?

A:

Intended Purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation (MDR, Article 2)

Q:

What is a medical device?

A:

Article 2, MDR 2017/745

'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific purposes: 

  • diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, 
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, 

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following shall also be deemed to be medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and those referred in the first paragraph of this point (NOTE: refer also to Annex XVI of MDR)
Q:

what is an in vitro diagnostic medical device?

A:

Article 2, IVDR 2017/746

'in vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

  1. concerning a physiological or pathological process or state;
  2. concerning congenital physical or mental impairments;
  3. concerning the predisposition to a medical condition or a disease;
  4. to determine the safety and compatibility with potential recipients;
  5. to predict treatment response or reactions;
  6. to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

This regulation does not apply to:

  1. products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
  2. invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
  3. internationally certified reference materials;
  4. materials used for external quality assessment schemes.


Q:

What is DiGA / DGV / DiGAV?

A:

DiGA (Digitale Gesundheitsanwendungen / Apps on prescription)
DGV (Digitale-Versorgung-Gesetz)
DiGAV (Digitale Gesundheitsanwendung Verordnung)

Q:

DGV / DiGAV: some facts

A:
  • DGV introduced the “app on prescription” in December 2019.
  • Persons covered by the German statutory health insurance are entitled to use a DiGA
    prescribed by a physician or psychotherapist and are reimbursed by the health insurance.
  • Prerequisite is that a DiGA must have successfully completed the assessment of the
    BfArM leading to a listing in the DiGA directory.
  • The process for the listing is defined in the DiGAV.
  • Costs for listing of device: EUR 3’000 – 9’900 (+ advice by BfArM EUR 250-5000)
Mehr Karteikarten anzeigen
Q:

DiGA – Required properties

A:

A DiGA is a “digital assistant in the hands of the patient”.
CE-marked medical device that has the following properties:

  • Medical device of the risk class I or IIa (according to the Medical Device Regulation (MDR)
  • The main function of the DiGA is based on digital technologies. The medical purpose is mainly achieved by way of its digital function.
  • The DiGA supports the recognition, monitoring, treatment or alleviation of diseases or the recognition, treatment, alleviation or compensation of injuries or disabilities. It does not service primary prevention and it does not serve only for the collection of data from a device or for controlling a device.
  • The DiGA is used by the patient alone or by patient and healthcare provider together.
  • A DiGA can also comprise devices, sensors or other hardware in addition to software, such as wearables, as long as the main function is a predominantly digital one (needs to be evaluated case-specific)
  • A DiGA can also comprise services (however, positive healthcare has to be proven without considering the service (needs to be evaluated case-specific)
Q:

DiGAV – Development Requirements (1/2)

A:
  • Requirements for data protection & information security
    • as of 1.1.2022 ISO 27001 certification is required!
  • Requirements for interoperatibility
    • should enable the continuous flow of information between all those involved in the healthcare system and their IT systems
    • Preferably MIO or vesta standards
  • Further quality requirements (robustness, user friendliness, functionality)
    • No data loss due to i.e. power supply failure
    • Easy to use
  • Checklists are provided by BfArM (Appendix 1 and 2 of DiGAV)
Q:

DiGAV – Development Requirements (2/2)

A:
  • Evidence of positive healthcare effect (!)
    • Legal Manufacturer must prove that the use of the device is better than not using it
    • In this context, non-use means that a patient may be treated (comparison group)
      • with something else, or
      • not treated at all, or
      • with a comparable and already listed DiGA.
    • The choice comparison group must be oriented on the current practice.
  • (Clinical) Study in Germany is required and full results must be published


It is possible to get feedback from BfArM regarding DIGA:
https://www.bfarm.de/DE/BfArM/OrganisationAufgaben/Beratungsverfahren/Innovationsbue
ro/_node.html

Q:

Classification: in accordance to what?

A:

MDR: Classification is carried out in accordance with Annex VIII of Regulation 2017/745


IVDR: Classification is carried out in accordance with Annex VIII of Regulation 2017/746

Q:

Examples of Class I MDR

A:
  • Wheelchair
  • Otoscope
  • Hospital Beds
Q:

Examples for MDR Class I* 

A:
  • Sterile Products (Is) 
  • Products with measuring function (Im)
  • Reprocessable surgical instruments (Ir)
Q:

What is regulatory affairs?

A:

Profession developed by governments to protect public health by controlling the safety and efficacy of products

"It's the law"

Regulatory Affairs and its Applications (Medical Devices)

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