EU - Chapter 3 Flashcards
MD classification was developed to apply appropriate ___ ___ ___ to MDs.
conformity assessment procedures
The classification of MDs is a ___ ___ ___ based on a human body’s vulnerability.
risk-based system
Council Directive ___ is known as MDD.
93/42/EEC
Council Directive ___ is AIMDD.
90/385/EEC
Council Directive ___ is IVDD.
98/79/EEC
MDD, AIMDD, and IVDD have been transposed into ___ ____ by each ___ ___.
national legislation, EU member state
On ___ new regulations were adopted and included ___ ___ and ___ ___.
04/05/17, EU MDR, EU IVDR
Regulation (EU) ___ replaces the MDD and AIMDD.
2017/745 (EU MDR)
What are the transitional periods and Dates for MDR and IVDR?
3 years May 2020 and 5 years (May 2022)
Read through MDR improvements (pages 38-39).
N/A
THe EU MDR is based on the ___ ___ principles of ___ ___ and ___.
New Approach, technical harmonization, standards
The manufacturer must demonstrate its MD complies with MDR Annex 1, ___ ___ ___ ___ ___ which are similar to the MDD Essential Requirements.
General Safety and Performance Requirements (GSPR)
To comply to GSPR the manufacurer must carry out ___ ____ which depends on ___ ___.
conformity assessment, device’s classification
Deadline to update to current ISO 13485 is ___.
March 2019
Two timelines should be considered when planning MDD to MDR transition and include:
- MDR
2. ISO 13485:2016(E)
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 ___ ___.
AR, DoC, CE mark, legislative requirements, CE mark
The 1st device classification (DC) step is determining if product falls within definition of a ___ ____.
MD
When classifying a MD what two things does one take into account?
intended purpose and inherent risks
MDR includes ___ classification rules subdivided into ___ groups including…
22, 4, noninvasive devices (Rules 1-4), invasive devices (Rules 5-8, including AID), active devices (Rules 9-13), special rules (Rules 14-22),
Special device categories fall outside the classification system and include:
custom-made devices, investigational devices, compassionate ground devices.
The manufacturer determines the device’s class using the classification principles and rules based on the device’s ___ ___and ___ ___.
Intended purpose, mode of action
Does EU MDD and MDR have the same definition for intended purpose?
Yes
Often, 2 or more rules may apply to the device in such case the ___ possible classification applies.
highest
The 5 key concepts of the EU classification system are:
time period, degree of invasiveness, energy use, biological activity, incorporation of drugs
