Rule number string | Ruletitle string | General explanation string | Class string | Rule string | Examples string | Practical Issues of classification string |
|---|---|---|---|---|---|---|
Rule 21 | Devices composed of substances that are introduced via a body orifice or applied to the skin | This rule covers a wide range of exclusively substance-based medical devices. In this context, ‘substance’ means any matter that is part of the
medical device, including those according to the definition of ‘substance’ in Article 1(3) of Directive 2001/83/EC. This is provided that they are
not excluded by the MDR (e.g.... | IIa (Klasse 2a) | — class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as
the pharynx1, and achieve their intended purpose on those cavities; and | - Substance-based formulations for skin
treatment
- Salt water used e.g. as nose or throat
sprays
- Oral cough treatments achieving their
intended purpose in the oral cavity as far
as the pharynx | Products acting in the nasal or oral cavity may be to some extent be ingested or inhaled. These products will be class IIa devices if the products
achieve their intended purpose solely in these cavities, and not in the respiratory tract, stomach or lower gastrointestinal tract.
N.B.: examples provided do not imply tha... |
Rule 21 | Devices composed of substances that are introduced via a body orifice or applied to the skin | This rule covers a wide range of exclusively substance-based medical devices. In this context, ‘substance’ means any matter that is part of the
medical device, including those according to the definition of ‘substance’ in Article 1(3) of Directive 2001/83/EC. This is provided that they are
not excluded by the MDR (e.g.... | IIb (Klasse 2b) | — class IIb in all other cases. | - Simethicone preparations for oral
administration
- Active coal for oral administration
- Gel for vaginal moisturizing / vaginal
lubricants
- Eye drops for hydration
- Ear drops1, 2
- Medical devices, for oral administration,
for the treatment of diarrhoea, e.g. kaolin,
diosmectite
- Medical devices, for oral ad... | Products acting in the nasal or oral cavity may be to some extent be ingested or inhaled. These products will be class IIa devices if the products
achieve their intended purpose solely in these cavities, and not in the respiratory tract, stomach or lower gastrointestinal tract.
N.B.: examples provided do not imply tha... |
null | null | null | null | null | null | null |
Rule 22 | Active therapeutic devices, with an incorporated diagnostic function | This rule is intended for therapeutic devices whose intended functionality is dependent to a significant degree on an integrated or incorporated
diagnostic function.
Automated or ‘closed-loop’ therapeutic systems are systems in which relevant biological conditions are automatically monitored (uses feedback
from physiol... | III (Klasse 3) | Active therapeutic devices with an integrated or incorporated diagnostic function1 which
significantly determines the patient management by the device, such as closed loop systems
or automated external defibrillators, are classified as class III. | - Automated external defibrillators (AED)
including their pads/electrodes
- Semiautomatic external defibrillators
- Automated closed loop insulin delivery system
- Automated external infusion pumps with
integrated sensors to adapt the infusion therapy
- Devices in brain-computer interfaces (BCIs) –
used for e.g. mo... | Note 1. ‘Integrated or incorporated diagnostic function’ means the functionality of a system including a physiological sensors e.g. the AED
electrodes/pads using a feedback control to process and record changes in the patient’s physiological state to continuously adjust a therapy.
The diagnostic function can be physica... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.