EU Regulations Flashcards
(21 cards)
European Council Directives
- AIMDD (1990)
- MDD (1993)
- IVDMD (1998)
- NEW regulations in 2021
What do the new regulations entail?
Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR): more post-market surveillance, more traceability, clearer definitions
What do the new rules apply to (primarily)?
- software
- nanomaterials
- ingested products
- nonviable human tissue, cells & derivatives
Four MDR device classes
- Class I
- Class IIa
- Class IIb
- Class III
Rule groupings
Rules 1-4: non-invasive
Rules 5-8: invasive devices
Rules 9-13: active devices
Rules 14-22: special rules
‘Invasive device’
- any device which penetrates inside the body
‘Active device’
- any device that depends on a source of energy other than that generated by the human body
- includes software
Duration of contact and divisions
Transient: continuous use for under 60 minutes
Short term: between 60 minutes and 30 days
Long term: more than 30 days
(long contact poses a greater risk)
Degree of invasiveness
- device which penetrates inside the body is invasive
- surgically invasive, implantable, introduced through surgical intervention, intended to remain after the procedure for at least 30 days
Other medical device classification rules
- is the device re-useable?
- is the device active (depends on source of energy)?
- part of the body affected
22 Rules:
Rules 1-4: classifying non-invasive devices into class I, IIa or IIb, or (in the rare case of vitro/direct human cell contact) class III
Rules 5-8: invasive device classifications, from time duration, bodily positioning, and activity within the body
Rules 9-13: classifying active devices based on their purposes, (identification, diagnosis, etc.), and specific rules on software
Rules 14-22: special rules
Contents of special rules
- deriving from plasma, contraception, contact lenses, x-rays, tissues derivations, nanomaterials, absorption or application of substances, and integrated/incorporated diagnostic functions
Quick Guide (Rules 1-4)
- covering non-invasive
- they do not touch the patient or only contact intact skin
- channeling/storing, modifying chemical composition, or those contacting injured skin
Quick Guide (Rules 5-8)
- invasive devices, introduced through a break in the skin or opening in the body
- body orifices, surgically invasive devices (for each time duration)
Quick Guide (Rules 9-13)
- active devices
- any device relying on a source of power other than that directly generated by the human body or gravity
- active therapeutic devices, diagnosis and monitoring devices, software for providing information, and those that are meant to administer or remove products
Quick Guide (Rules 14-22)
- includes the four new MDR rules
- cannot be categorised into the other sets
In-Vitro Diagnostics Regulation
- different classification for in vitro devices (IVDs): it is a list based rather than risk-based rules approach
- Class A (lowest risk) to Class D (highest)
Class D Devices (IVDR)
- devices to detect presence of transmissible agents, determining life-threatening disease loads, etc.
Class C Devices (IVDR)
- devices for blood grouping or tissue typing (ex: for transfusion or transplants)
- and a ton more…
Class B (IVDR)
- detecting pregnancy, fertility, cholesterol, and urine samples
- also a catch-all for anything that doesn’t fit in other categories
Class A (IVDR)
- general lab use, specimen receptacles, etc.
