RAC Exam - EU MDD/AIMDD & MDR NEWEST ACTUAL
COMPLETE 120 REAL EXAM QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY
GRADED A+(2025/2026)
Whish entity is legally responsible for compliance with
regulations and the first point of contact for EU authorities? -
ANSWER-Authorised Representative (as applicable, if not the
manufacturer itself)
Which entity is liable for defective products in the post market
phase – ANSWER-Authorised rep
What specific characteristics of the product should be taken in
to consideration when determining if it's a medical device -
ANSWER-1. intended use
2. indications for use
3. mode of action
IVDD differentiates between products for professional and ___
use. – ANSWER-Patient
,Define 'self testing' - ANSWER-any device intended by the maf
as used by lay persons
Which annex in the MDD contains principles that must be
understood before applying classification rules. - ANSWER-
Annex 9 (IX)
The devices intended purpose must be achieved by a
describable _____ supported by scientific ______ - ANSWER-
mode of action, evidence
The manf must consider --- the classification rules - ANSWER-all
Individual devices used in a system can be classified .... or the
system can be classified as a whole, in which case the items in
the ____ classification is the class for the entire system -
ANSWER-in their own right, higher
What are the key device characteristics and uses the
classification system is built upon? (5) - ANSWER-time
period/duration degree of invasiveness energy use biological
activity incorporation of drugs
Time period categories and duration (3) - ANSWER-transient -
less than 60 minutes
, short-term - between 60 minutes and 30 days
long-term - more than 30 days
Invasiveness involved a devices ____ of the body - ANSWER-
penetration - either thru a body orifice or thru the surface of the
body
needles used for injection are regarded as ___ ____ - ANSWER-
surgically invasive
What are surgically invasive subtypes? (2) - ANSWER-implants
and reusable surgical instruments
risk classification relates to risk-factors the manufacturer ... but
not ... - ANSWER-can influence, those outside the manufacturers
control
define implant - ANSWER-any device
intended to - be introduced totally into
the human body
- to replace epithelial surface or surface of eye
- be partially introduced into the body through surgical
intervention and intended to remain in place for at least 30 days
COMPLETE 120 REAL EXAM QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY
GRADED A+(2025/2026)
Whish entity is legally responsible for compliance with
regulations and the first point of contact for EU authorities? -
ANSWER-Authorised Representative (as applicable, if not the
manufacturer itself)
Which entity is liable for defective products in the post market
phase – ANSWER-Authorised rep
What specific characteristics of the product should be taken in
to consideration when determining if it's a medical device -
ANSWER-1. intended use
2. indications for use
3. mode of action
IVDD differentiates between products for professional and ___
use. – ANSWER-Patient
,Define 'self testing' - ANSWER-any device intended by the maf
as used by lay persons
Which annex in the MDD contains principles that must be
understood before applying classification rules. - ANSWER-
Annex 9 (IX)
The devices intended purpose must be achieved by a
describable _____ supported by scientific ______ - ANSWER-
mode of action, evidence
The manf must consider --- the classification rules - ANSWER-all
Individual devices used in a system can be classified .... or the
system can be classified as a whole, in which case the items in
the ____ classification is the class for the entire system -
ANSWER-in their own right, higher
What are the key device characteristics and uses the
classification system is built upon? (5) - ANSWER-time
period/duration degree of invasiveness energy use biological
activity incorporation of drugs
Time period categories and duration (3) - ANSWER-transient -
less than 60 minutes
, short-term - between 60 minutes and 30 days
long-term - more than 30 days
Invasiveness involved a devices ____ of the body - ANSWER-
penetration - either thru a body orifice or thru the surface of the
body
needles used for injection are regarded as ___ ____ - ANSWER-
surgically invasive
What are surgically invasive subtypes? (2) - ANSWER-implants
and reusable surgical instruments
risk classification relates to risk-factors the manufacturer ... but
not ... - ANSWER-can influence, those outside the manufacturers
control
define implant - ANSWER-any device
intended to - be introduced totally into
the human body
- to replace epithelial surface or surface of eye
- be partially introduced into the body through surgical
intervention and intended to remain in place for at least 30 days
