Chapter 5 GSPR and Technical Documentation Flashcards
On _______, EC published EU MDR and EU IVDR.
April 5, 2017
EU MDR and IVDR include __ GSPR for MD (___ for IVD) in Annex __, compared to the previous version’s __.
23, 20, 1, 13
GSPR stands for
General Safety and Performance Requirements
The Essnetial Principles concept was devloped by
Global Harmonization Task Force
Prior to CE marking, conformity to all ___ contained in Annex I of the regulations must be demonstrated.
GSPRs
A GSPR checklist should not include ___ details but should include ___ to which compliance has been claimed.
technical, standards
A standard is a ____ document.
concensus
GHTF viewed international concensus standrads as a tool for ___ regulatory processes to ensure MD’s safety, quality and performance.
harmonizing
___ ___ 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.
Common Specifications (CS)
___ ___ was adopted in 1985 and is based on the principle of establising an internal European market with free movement of goods and services.
New Approach
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 ___.
harmonization
Generic standards, relevant to all devices or a wide range of product types are ___ standards.
horizontal
__ standards contain requirements applicable to a wide range of similar products.
semihorizontal
__ standards apply to single product types or a range of closely related products.
vertical
Technical documentation is described in EU MDR and IVDR in Annexes __ and __ and cover device’s ___, ___, and ___.
II, III, design, performance, manufacture
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.
10, 15
Technical Documentation includes:
- device description; 2. labelling; 3. design/manufacturing info; 4. GSPR; 5. risk managment; Verification/validation
TD for PMS includes:
PMS plan and PSUR/PMS report
EU medical device regulatory review process does not require comparison to a ___ device.
predicate
___ for MD design and manufacture ensure patient, user, and 3rd party’s health and safety are protected.
GSPRs
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.
Standard
To ensure ___ ___ are met, a manufacturer may use consensus standards.
EP
Inherent in the ___ ___ is the expectation that compliance with these specifications provides a presumption of conformity with the ___.
New Approach, GSPRs
A ___ ___ is deemed necessary and sufficient to carry the presumption of conformity with the relevant European regulations ___.
Harmonized standard, GSPRs
