Chapter 5 GSPR and Technical Documentation

Question 1

On _______, EC published EU MDR and EU IVDR.

Answer 1

April 5, 2017

Question 2

EU MDR and IVDR include __ GSPR for MD (___ for IVD) in Annex __, compared to the previous version’s __.

Answer 2

23, 20, 1, 13

Question 3

GSPR stands for

Answer 3

General Safety and Performance Requirements

Question 4

The Essnetial Principles concept was devloped by

Answer 4

Global Harmonization Task Force

Question 5

Prior to CE marking, conformity to all ___ contained in Annex I of the regulations must be demonstrated.

Answer 5

GSPRs

Question 6

A GSPR checklist should not include ___ details but should include ___ to which compliance has been claimed.

Answer 6

technical, standards

Question 7

A standard is a ____ document.

Answer 7

concensus

Question 8

GHTF viewed international concensus standrads as a tool for ___ regulatory processes to ensure MD’s safety, quality and performance.

Answer 8

harmonizing

Question 9

___ ___ refers to technical and/or clinical requirements, other than a standard, that provide a means of complying with the legal obligations applicable to a device, process ot system.

Answer 9

Common Specifications (CS)

Question 10

___ ___ was adopted in 1985 and is based on the principle of establising an internal European market with free movement of goods and services.

Answer 10

New Approach

Question 11

Once a standard has been approved for publication as a European standard, CEN advisors review it to verify it demonstrates conformity assessment. If it is found to be adequate, a reference to standard is published in the Offical Journal of European Communtities (OJ) This is ___.

Answer 11

harmonization

Question 12

Generic standards, relevant to all devices or a wide range of product types are ___ standards.

Answer 12

horizontal

Question 13

__ standards contain requirements applicable to a wide range of similar products.

Answer 13

semihorizontal

Question 14

__ standards apply to single product types or a range of closely related products.

Answer 14

vertical

Question 15

Technical documentation is described in EU MDR and IVDR in Annexes __ and __ and cover device’s ___, ___, and ___.

Answer 15

II, III, design, performance, manufacture

Question 16

Per MDR and IVDR, the minimum technical documentation retention period for the legal manufacturer is ___ years after the last device being placed on market and ___ for implantable devices.

Answer 16

10, 15

Question 17

Technical Documentation includes:

Answer 17

1. device description; 2. labelling; 3. design/manufacturing info; 4. GSPR; 5. risk managment; Verification/validation

Question 18

TD for PMS includes:

Answer 18

PMS plan and PSUR/PMS report

Question 19

EU medical device regulatory review process does not require comparison to a ___ device.

Answer 19

predicate

Question 20

___ for MD design and manufacture ensure patient, user, and 3rd party’s health and safety are protected.

Answer 20

GSPRs

Question 21

A ___ is a document established by consensus and approved by a recognized body, which provides, for common and repeated use,rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.

Answer 21

Standard

Question 22

To ensure ___ ___ are met, a manufacturer may use consensus standards.

Answer 22

EP

Question 23

Inherent in the ___ ___ is the expectation that compliance with these specifications provides a presumption of conformity with the ___.

Answer 23

New Approach, GSPRs

Question 24

A ___ ___ is deemed necessary and sufficient to carry the presumption of conformity with the relevant European regulations ___.

Answer 24

Harmonized standard, GSPRs

Question 25

Using HS to demonstrate compliance with GSPRs is required (T/F).

Answer 25

F

Question 26

Prior to MDR and IVDR entering into force, manufacturers can use recommendations from ___ to structure the TF.

Answer 26

NB-MED

Question 27

NB-MED stands for

Answer 27

European Association of Medical Device Notified Bodies

Question 28

The manufacturer can compile full technical documentation or a summary, the later derived from___ developed by GHTF.

Answer 28

STED

Question 29

STED stands for

Answer 29

Summary Technical Documentation

Question 30

TD includes:

Answer 30

Pg. 63

Question 31

TD on PMS is defined in Annex ___ and is in line with the ___ to ensure reductions safety via proactive market surveillance.

Answer 31

III, NLF

Question 32

TD on PMS includes:

Answer 32

PMS plan and PSUR/PMS report

Question 33

___ ___ refers to an established device bearing CE mark that is used as the reference in a clinical investigation.

Answer 33

Comparator device