SBS - The Best Value in QMS software

MDR Reporting for event with RUO instrument

R

RA2010

#1
Hello everyone,

I'm not sure if anyone else has come across this situation but any insight would be much appreciated :)

If an event occurs with an RUO instrument, which is also marketed as an IVD in the US does the event need to be reviewed for MDR? Or would it be exempt because the event occurred in relation to the RUO version and not the IVD version? This is assuming that the same event can occur on the IVD product.

Thanks!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
Sorry for the slow response time... holidays and all.

The regulation (820.198(c)) says that "Any complaint involving the possible failure of a device..." (emphasis added). So, yes, if you get any inkling that use of your product could cause an event, you should conduct the review.
 
Thread starter Similar threads Forum Replies Date
E Reporting Requirements - Report to US FDA if a MDR event happened outside US Other US Medical Device Regulations 3
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
T Trend Reporting under the EU MDR EU Medical Device Regulations 12
J MDR reporting and CAPA thoughts? Classifying Complaints on Risk 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
B Is there a MDR (Medical Device Reporting) equivalent in China ? China Medical Device Regulations 1
C New draft MDR reporting guidance Other US Medical Device Regulations 1
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
E Post Inspection Regulatory Action by US FDA - 21 CFR 803 - MDR Reporting Other US Medical Device Regulations 4
W MDR Reporting - How to interpret requirements for MDR Other US Medical Device Regulations 14
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 2
H MDR Article 13(c) EU Medical Device Regulations 5
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 0
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 0
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H MDD VS MDR 2002-218 UK Medical Device Regulations 6
Ed Panek MDR Liability Insurance EU Medical Device Regulations 1
S MDD to MDR - Tallow Derivatives Impact EU Medical Device Regulations 1
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
S MDR GSPR Standards EU Medical Device Regulations 1
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 3
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 3
C MDR Classification Rule 10 EU Medical Device Regulations 13
C MDR software classification EU Medical Device Regulations 12
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
R Products not within the MDR grace period EU Medical Device Regulations 1
shimonv MDR transition checklist EU Medical Device Regulations 0
K Re-packaging under MDR EU Medical Device Regulations 3
Ed Panek Upcoming NB MDD ---> MDR Crunch EU Medical Device Regulations 0
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
JoCam Rental and MDD versus MDR EU Medical Device Regulations 1

Similar threads

Top Bottom