EU Regulations II Flashcards
(10 cards)
1
Q
CE marking
A
- certifies that a product has met European Directives regarding consumer safety, health, or environmental requirements
- allows device to be placed on the Irish/European market
- NSAI (notified body) designated by HPRA (national competent authority) to perform conformity assessments… after which a CE mark is awarded
2
Q
CE requirement major categories
A
- safety and reliability
- quality system
3
Q
Technical Documentation 7 key elements
A
- device description
- information to be supplied by the manufacturer (labels, instructions for use)
- design and manufacturing information
- general safety and performance requirements
- benefit-risk analysis and risk management
- product verification and validation
7) for classes IIa, IIb, and III, periodic safety report
4
Q
Conformity assessment
A
- laid out in Annexes IX to XI of MDR
- shows that the medical device complies with proper requirements
5
Q
Annex IX conformity route
A
- full Quality Management System (QMS) implemented by the manufacturer
- review of technical documentation is also necessary
- full or partial compliance? depends on classification
6
Q
Annex X conformity route
A
- used when a manufacturer wants to certify a device based on a representative sample
- NSAI examines and/or tests this sample and associated documentation to determine if requirements are met
7
Q
Annex XI conformity route
A
- used in association with Annex X or in combination with technical documentation
- two parts: production quality assurance and product verification
8
Q
Class I conformity requirements
A
- for self-certified, just need to maintain technical documentation
- sometimes need a limited QMS to control production or a special characteristic
9
Q
Class IIa conformity requirements
A
- review of full QMS through Annex IX (same as procedure for a Class IIb non-active/implantable device)
- OR, build technical documentation and select route based on production control/Annex XI
10
Q
Class III conformity requirements
A
- Annex XI including full Quality Assurance audit and full documentation review
- expert panel involved in evaluating implantable devices
- can look to possess an EU QMS (EN ISO 13485)
- or purse Annex X (type-examination) in combination with Annex XI Part A or B
