EU - Chapter 1

Question 1

MDD stands for…

Answer 1

Medical Device Directive, Directive 93/42/EC

Question 2

EU MDR stands for…

Answer 2

European Union Medical Device Regulation

Question 3

AIMDD stands for…

Answer 3

Active Implantable Medical Device Directive, Directive 90/385/EEC

Question 4

EU MDR replaces…

Answer 4

MDD and AIMDD

Question 5

IVDR stands for…

Answer 5

In Vitro Diagnostic Device Regulation

Question 6

EU IVDR replaces…

Answer 6

IVD Directive 98/79/EC

Question 7

AIMD are what class?

Answer 7

III

Question 8

MDCG stands for…

Answer 8

Medical Device Coordination Group

Question 9

What does the MDCG do?

Answer 9

make borderline decisions on product qualification

Question 10

Will products utilizing non viable human tissue/cells be regulated under the new MDR?

Answer 10

Yes

Question 11

EU IVDR provides specific definitions/reg. requirements for devices for: a. self-testing; b. near patient testing; c. single-use; d. kits; e. all of the above?

Answer 11

e.

Question 12

A devices that assist is _________.

Answer 12

accessory

Question 13

M in MAID stands for:

Answer 13

manufacturer

Question 14

A in MAID stands for:

Answer 14

authorized representative

Question 15

I in MAID stands for:

Answer 15

importer

Question 16

D in MAID stands for:

Answer 16

distributor

Question 17

The economic operators covered by the new supply chain regime is…

Answer 17

MAID

Question 18

Under which system does only the manufacturer have regulatory obligations?

Answer 18

MDD

Question 19

UDI means…

Answer 19

unique device identifier

Question 20

The EU has set up what that will assign UDIs to all medical devices?

Answer 20

traceability system

Question 21

Will custom-made and investigational devices have UDIs

Answer 21

yes

Question 22

UDI will be used to:

Answer 22

reporting serious incidents and FSCA and be given to the patient.

Question 23

UDI implementation will happen when?

Answer 23

2021 onwards

Question 24

NB will play a role in enforcement by:

Answer 24

conducting unannounced inspections of manufacturing processes.

Question 25

Grandfathering of NB will occur under MDR?

Answer 25

No

Question 26

Premarket assessment (PMA) primarily involves

Answer 26

higher-risk MD

Question 27

PMA will be supervised by...

Answer 27

EMA = European Medicines Agency

Question 28

Currently ______ IVDs are CE certified but under MDR ________ will need to be certified.

Answer 28

10-20%, 80-90%

Question 29

MDR will require more

Answer 29

clinical evidence

Question 30

MDR will not __________ existing devices.

Answer 30

grandfather

Question 31

PSUR stands for

Answer 31

Periodic Safety Update Reports

Question 32

Examples of MDR reclassification is:

Answer 32

up-classify substance based MD, software on class IIa or higher, orthopedic devices to class III, and reusable surgical tools to class Ir.

Question 33

IVD proposed system is...

Answer 33

4 risk classes (A-D).

Question 34

OBL is

Answer 34

own brand labeling

Question 35

_________ is not harmonized under EU law.

Answer 35

single-use medical device reprocessing

Question 36

Transitional period b/t MDR entry into force and date of application is ___ years for EU MDR and ___ years for EU IVDR.

Answer 36

3, 5

Question 37

What will happen w/ existing CE certs after MDR enter into force?

Answer 37

Certs under MDD remain valid till end of period on the cert.