Chapter 8 MD Conformity Assessment Procedure

Question 1

The key conformity assessment procedure issue is demonstrating a MD meets the ___ ___ regarding quality, safety, performance, user and environmental protection over its entire lifetime.

Answer 1

EP

Question 2

Who is involved in the CE marking process? 
A. CA
B. NB
C. AU
D. All of the Above

Answer 2

D

Question 3

Are NB nominated by EU member state to monitor and ensure compliance with MDD compliance?

Answer 3

No, CA are nominated by their govements in every member state.

Question 4

Who designates 1 or more NB to ensure conformity assessment procedures are completed according to relevant criteria?

Answer 4

CA

Question 5

The ___, designated by the ___, is legally responsible for compliance with regulations and is the first point of contact for EU authorities.

Answer 5

AR, manufacturer

Question 6

Under MDD, AR are liable for defective products in the post market phase. T/F

Answer 6

F, under MDR AR is responsible.

Question 7

It is the __ responsibility to ensure product complies with the relevant EU Legislation’s Essential Requirements (ER).

Answer 7

Manufacturer’s

Question 8

Under MDR the ER correlates to the

Answer 8

Essential Principles (EP)

Question 9

General overview of CE marking process.

Answer 9

Pg. 80-81

Question 10

MD are covered by EU __ ___ ___ which specifies the ER/EP with which products must comply and the conformity assessment route tone followed.

Answer 10

New Approach Legislation

Question 11

The New Approach regulatory frameworks favors the ___ priniclple.

Answer 11

Conformity

Question 12

Conformity principle means a MD’s conformity with ___ EU ___ provisions confirms device meets presumption of conformity with the applicable EO MDD’s ___ ___.

Answer 12

Harmonized standard, ER

Question 13

Lists of harmonized standards are published in…

Answer 13

Official Journal of the EU

Question 14

A standard harmonized ed with current directives is automatically harmonized with new regulations.

Answer 14

False

Question 15

The ___ ___ ___ primary goal is to create a multiple, unified, free EU market across the 28 states and other countries aligned with EU legislation.

Answer 15

New Approach Legislation

Question 16

The conformity assessment procedure type to be conducted and the extent to which an independent testing and NB is required depends on the product’s potential ___.

Answer 16

Risk

Question 17

MDD differentiates devices into ___ risk levels and include…

Answer 17

4, I, IIa, IIb, III

Question 18

MD classification rules address an approach based on ___, ___, ___ and ___ ___.

Answer 18

Risk, invasiveness, technology, and intended use

Question 19

Manufactures must choose from a very specific list of conformity assessments procedures to demonstrate compliance with procedure?

Answer 19

False, range of conformity assessments.

Question 20

Manufacturers may choose b/t using applicable EU ___ ___, ___ or ___ standards or use their own test specifications.

Answer 20

Harmonized standards, international, national

Question 21

Most preferred method is

Answer 21

Using harmonized standards.

Question 22

Elements used in conformity assessment procedure are:

Answer 22

QMS, PMS system, technical documentation supporting compliance with ER, and DoC

Question 23

For class III devices with medicinal products, aspects described in annexes need not be considered in the conformity assessment procedure.

Answer 23

False, must be considered.