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According to the Medical Device Regulation (EU) 2017/745, who is considered an economic operator?
According to the Medical Device Regulation (EU) 2017/745, who is considered an economic operator?
- Authorized Representative
- Manufacturer (correct)
- Importer
- Distributor
Who is responsible for the regulatory compliance of medical devices according to Article 15 of the Medical Device Regulation (EU) 2017/745?
Who is responsible for the regulatory compliance of medical devices according to Article 15 of the Medical Device Regulation (EU) 2017/745?
- Person Responsible for Regulatory Compliance (PRRC) (correct)
- Importer
- Authorized Representative
- Manufacturer
Which of the following is not considered an economic operator under the Medical Device Regulation (EU) 2017/745?
Which of the following is not considered an economic operator under the Medical Device Regulation (EU) 2017/745?
- Importer
- Notified Body (correct)
- Authorized Representative
- Manufacturer
Who can combine medical devices or procedure packs according to Article 22(1) of the Medical Device Regulation (EU) 2017/745?
Who can combine medical devices or procedure packs according to Article 22(1) of the Medical Device Regulation (EU) 2017/745?
Who is responsible for sterilized systems or procedure packs according to Article 22(3) of the Medical Device Regulation (EU) 2017/745?
Who is responsible for sterilized systems or procedure packs according to Article 22(3) of the Medical Device Regulation (EU) 2017/745?
Which of the following is considered a non-invasive medical device?
Which of the following is considered a non-invasive medical device?
Which classification rule applies to a blood bag?
Which classification rule applies to a blood bag?
What is the duration of use for a long-term medical device?
What is the duration of use for a long-term medical device?
Which conformity assessment process requires partial notified body certification?
Which conformity assessment process requires partial notified body certification?
Which classification applies to a sterile, reprocessed medical device with a measuring function and high risk?
Which classification applies to a sterile, reprocessed medical device with a measuring function and high risk?
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Study Notes
Economic Operators
- According to the Medical Device Regulation (EU) 2017/745, an economic operator is a manufacturer, authorized representative, importer, or distributor.
Regulatory Compliance
- The manufacturer is responsible for the regulatory compliance of medical devices according to Article 15 of the Medical Device Regulation (EU) 2017/745.
Non-Economic Operators
- A healthcare professional or a patient is not considered an economic operator under the Medical Device Regulation (EU) 2017/745.
Combination of Medical Devices
- A manufacturer, authorized representative, or importer can combine medical devices or procedure packs according to Article 22(1) of the Medical Device Regulation (EU) 2017/745.
Sterilized Systems or Procedure Packs
- The manufacturer is responsible for sterilized systems or procedure packs according to Article 22(3) of the Medical Device Regulation (EU) 2017/745.
Non-Invasive Medical Devices
- A portable defibrillator is considered a non-invasive medical device.
Classification of Blood Bags
- Rule 8 applies to the classification of a blood bag.
Duration of Use
- A long-term medical device has a duration of use more than 30 days.
Conformity Assessment
- The self-certification process requires partial notified body certification.
Classification of Sterile, Reprocessed Medical Devices
- A sterile, reprocessed medical device with a measuring function and high risk is classified as Class IIb.
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