Chapter 8 MD Conformity Assessment Procedure Flashcards
The key conformity assessment procedure issue is demonstrating a MD meets the ___ ___ regarding quality, safety, performance, user and environmental protection over its entire lifetime.
EP
Who is involved in the CE marking process? A. CA B. NB C. AU D. All of the Above
D
Are NB nominated by EU member state to monitor and ensure compliance with MDD compliance?
No, CA are nominated by their govements in every member state.
Who designates 1 or more NB to ensure conformity assessment procedures are completed according to relevant criteria?
CA
The ___, designated by the ___, is legally responsible for compliance with regulations and is the first point of contact for EU authorities.
AR, manufacturer
Under MDD, AR are liable for defective products in the post market phase. T/F
F, under MDR AR is responsible.
It is the __ responsibility to ensure product complies with the relevant EU Legislation’s Essential Requirements (ER).
Manufacturer’s
Under MDR the ER correlates to the
Essential Principles (EP)
General overview of CE marking process.
Pg. 80-81
MD are covered by EU __ ___ ___ which specifies the ER/EP with which products must comply and the conformity assessment route tone followed.
New Approach Legislation
The New Approach regulatory frameworks favors the ___ priniclple.
Conformity
Conformity principle means a MD’s conformity with ___ EU ___ provisions confirms device meets presumption of conformity with the applicable EO MDD’s ___ ___.
Harmonized standard, ER
Lists of harmonized standards are published in…
Official Journal of the EU
A standard harmonized ed with current directives is automatically harmonized with new regulations.
False
The ___ ___ ___ primary goal is to create a multiple, unified, free EU market across the 28 states and other countries aligned with EU legislation.
New Approach Legislation
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 ___.
Risk
MDD differentiates devices into ___ risk levels and include…
4, I, IIa, IIb, III
MD classification rules address an approach based on ___, ___, ___ and ___ ___.
Risk, invasiveness, technology, and intended use
Manufactures must choose from a very specific list of conformity assessments procedures to demonstrate compliance with procedure?
False, range of conformity assessments.
Manufacturers may choose b/t using applicable EU ___ ___, ___ or ___ standards or use their own test specifications.
Harmonized standards, international, national
Most preferred method is
Using harmonized standards.
Elements used in conformity assessment procedure are:
QMS, PMS system, technical documentation supporting compliance with ER, and DoC
For class III devices with medicinal products, aspects described in annexes need not be considered in the conformity assessment procedure.
False, must be considered.
