SBS - The Best Value in QMS software

IVDD - IFU related requirements - Type of information/statement expected

#1
Hi and welcome everyone first of all (been using the Cove for a while now, but this is my first post).

I'm looking for some explanation what type of information/statement is expected to show compliance with the requirements listed in the Annex I, section B, clause 8.7:
point 8.7 (j): measures to be taken in the event of changes in the analytical performance of the device

point 8.7 (k): information appropriate to users on:
— internal quality control including specific validation procedures,
— the traceability of the calibration of the device

point 8.7 (l): the reference intervals for the quantities being determined, including a description of the appropriate reference population

I know that the Directive states "where appropriate, the IFU must contain the following particulars", so it may not be always required.

Thanks for help!
Jacek
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
B EU: Alcohol test kits for breast milk IVDD EU Medical Device Regulations 2
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
M Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) Medical Device and FDA Regulations and Standards News 5
L IVD Reagent Techncial File Review Requirements (IVDD Annex III) EU Medical Device Regulations 4
X Algeria IVDD Registration Requirements in English Other Medical Device Regulations World-Wide 2
C IVDD 98/79/EC Measuring Function Requirements EU Medical Device Regulations 2
L IVDD 98/79/EEC - Can I self declare? EU Medical Device Regulations 2
P Proposed Changes to the Medical Device Directive (and IVDD) EU Medical Device Regulations 0
M IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks? EU Medical Device Regulations 2
W New harmonised standards MDD and IVDD 2012/C 262 EU Medical Device Regulations 4
D IVDD RoHS Directive Compliance to 2011/65/EU RoHS, REACH, ELV, IMDS and Restricted Substances 4
R No Stability Standard on latest List of Harmonized Standards IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
I IVDD - Software and Graphics Standards or Guidance Documents EU Medical Device Regulations 3
W New Harmonized Standards MDD and IVDD EU Medical Device Regulations 5
W EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
D Labelling and IFU deadlines EU Medical Device Regulations 3
M Addition of IFU on local language by distributor - Article 16? EU Medical Device Regulations 1
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 6
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
J EU 207/2012 E-IFU Service Video EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
U Intended Users in IFU (Instructions for Use) EU Medical Device Regulations 5
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
K No IFU, where the requirements would go? EU Medical Device Regulations 5
P IFU Translation Requirements for EU EU Medical Device Regulations 2
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 5
K REF symbol with product code in the IFU EU Medical Device Regulations 1
F Control of medical device IFU content Other Medical Device and Orthopedic Related Topics 3
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S Providing IFU (Instructions for Use) in multiple languages EU Medical Device Regulations 0
S IFU on web page - Consequences if the most recent one is not uploaded EU Medical Device Regulations 3
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 15
H IFU in different language other than English EU Medical Device Regulations 5
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 1
Z IFU (Instructions for Use) Symbol - 7010:M002 - can it be in black? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
M EU Regulations or Standards for instruction for use (IFU ) EU Medical Device Regulations 3
K Label - IFU requirement, maybe? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Electrosurgical devices/surgery IFU contraindications EU Medical Device Regulations 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Product Instruction for Use Manual (IFU) - Obligation to list the standard used 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom