EU - Chapter 3

Question 1

MD classification was developed to apply appropriate ___ ___ ___ to MDs.

Answer 1

conformity assessment procedures

Question 2

The classification of MDs is a ___ ___ ___ based on a human body’s vulnerability.

Answer 2

risk-based system

Question 3

Council Directive ___ is known as MDD.

Answer 3

93/42/EEC

Question 4

Council Directive ___ is AIMDD.

Answer 4

90/385/EEC

Question 5

Council Directive ___ is IVDD.

Answer 5

98/79/EEC

Question 6

MDD, AIMDD, and IVDD have been transposed into ___ ____ by each ___ ___.

Answer 6

national legislation, EU member state

Question 7

On ___ new regulations were adopted and included ___ ___ and ___ ___.

Answer 7

04/05/17, EU MDR, EU IVDR

Question 8

Regulation (EU) ___ replaces the MDD and AIMDD.

Answer 8

2017/745 (EU MDR)

Question 9

What are the transitional periods and Dates for MDR and IVDR?

Answer 9

3 years May 2020 and 5 years (May 2022)

Question 10

Read through MDR improvements (pages 38-39).

Answer 10

N/A

Question 11

THe EU MDR is based on the ___ ___ principles of ___ ___ and ___.

Answer 11

New Approach, technical harmonization, standards

Question 12

The manufacturer must demonstrate its MD complies with MDR Annex 1, ___ ___ ___ ___ ___ which are similar to the MDD Essential Requirements.

Answer 12

General Safety and Performance Requirements (GSPR)

Question 13

To comply to GSPR the manufacurer must carry out ___ ____ which depends on ___ ___.

Answer 13

conformity assessment, device’s classification

Question 14

Deadline to update to current ISO 13485 is ___.

Answer 14

March 2019

Question 15

Two timelines should be considered when planning MDD to MDR transition and include:

Answer 15

1. MDR

2. ISO 13485:2016(E)

Question 16

Once all MDR obligations met, manufacturer or ___ must sign ___ and then affix ___ ___ to device to show it conforms to ___ ___. If NB involved, its identification number needs to be placed near the ___ ___.

Answer 16

AR, DoC, CE mark, legislative requirements, CE mark

Question 17

The 1st device classification (DC) step is determining if product falls within definition of a ___ ____.

Answer 17

MD

Question 18

When classifying a MD what two things does one take into account?

Answer 18

intended purpose and inherent risks

Question 19

MDR includes ___ classification rules subdivided into ___ groups including…

Answer 19

22, 4, noninvasive devices (Rules 1-4), invasive devices (Rules 5-8, including AID), active devices (Rules 9-13), special rules (Rules 14-22),

Question 20

Special device categories fall outside the classification system and include:

Answer 20

custom-made devices, investigational devices, compassionate ground devices.

Question 21

The manufacturer determines the device’s class using the classification principles and rules based on the device’s ___ ___and ___ ___.

Answer 21

Intended purpose, mode of action

Question 22

Does EU MDD and MDR have the same definition for intended purpose?

Answer 22

Yes

Question 23

Often, 2 or more rules may apply to the device in such case the ___ possible classification applies.

Answer 23

highest

Question 24

The 5 key concepts of the EU classification system are:

Answer 24

time period, degree of invasiveness, energy use, biological activity, incorporation of drugs

Question 25

The device’s duration is categorized into:

Answer 25

transient (<60 minutes), short-term (b/t 60 min and 30 days, long-term (more than 30 days).

Question 26

Difference b/t invasive and surgically invasive device

Answer 26

surgically invasive device produces penetration other than thru a body orifice.

Question 27

Two examples of surgically invasive device

Answer 27

needle for injection and surgical gloves

Question 28

EU MD classification system is based on ___ and ____ ____ listed in MDD Annex ___ and IVDD Annex ____.

Answer 28

rules, application principles, IX, II

Question 29

Two surgically invasive subtypes are

Answer 29

implants, reusable surgical instruments

Question 30

Integrating a drug into MD catorgises the drug/device as

Answer 30

Class III in most cases

Question 31

SW is classified same way as other MD except:

Answer 31

standalone SW is considered active MD, SW that drives a device falls into same class as the device.

Question 32

Per MDR, reclassification changes do require a full legislative process.

Answer 32

False

Question 33

MDCG means

Answer 33

MD Coordinating Group

Question 34

At request of ___ ___, the Commision consults the MDCG about reclassification.

Answer 34

member state

Question 35

A guidance is legally binding.

Answer 35

False

Question 36

Definition of IVD

Answer 36

pg. 43-44

Question 37

Manufcturers of Class ___, ___ and ___ devices (other than devices for performance studies) shall be subject to ___ ___.

Answer 37

B, C, D, conformity assessment

Question 38

Manufacturers of Class ___ In Vitro devices (other than devices for performance studies) shall declare the ___ of their product. by issuing EU ___ of ___, after drawing up the ____ ____.

Answer 38

A, Declaration of Conformity, Technical Documentation

Question 39

MDD includes ___ rules assigning devices into a risk class: __, __, __, and __.

Answer 39

18, I, IIa, IIb, III

Question 40

New IVDR will adopt ___-___ classification system following the ___ classification rules, with ___ classes or varying risk, from class A ( __ risk) to D ( ___ risk).

Answer 40

risk based, GHTF, 4, lowest, highest