RUO (Research Use Only) vs. IVD (In Vitro Diagnostic) - Differences

Q

QA Bee

#1
Can we use a RUO kit in an IVD registered equipment?
Will the IVD regulations (both in US and EU) permit this?

I understand that ASR products have to be claimed as IVD as soon as it's used on IVD equipment, so wondering if same rule applies with RUO products,
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
Re: RUO vs. IVD

For the EU:
IVD's that are placed on the market must comply with the IVD directive and carry the CE mark. An RUO by definition is intended for research use only, not clinical use and therefore does not meet the requirements of the directive.

If you want to add an RUO kit to IVD equipment and use it in a clinical setting then it must comply with the directive.
 

akp060

Involved In Discussions
#4
which are the regulations to follow to place an RUO reagent kit in Europe and USA?
Thanks!
Maria Elena
For USA, you can follow recommendations HERE. I am not sure if you would require Registration/Listing though. Any comments about registration/listing requirements, Exempt or Subject to Enforcement Discretion?
 

LukasLosigkeit

Starting to get Involved
#5
In practice, RUOs are used in laboratories for diagnostics. However, the laboratories then validate each RUO batch and associated procedures prior to use (Europe).
 

twanmul

Involved In Discussions
#6
In practice, RUOs are used in laboratories for diagnostics. However, the laboratories then validate each RUO batch and associated procedures prior to use (Europe).
This is true but under Regulation EU 2017/746 (IVDR), this will need to be covered through a Health Institution Exemption, where the conditions (Art. 5 (5)) can be met. This will mean a lot of changes are required from May 2022 to demonstrate conformity of each RUO that is used for a diagnostic purpose.
 

akp060

Involved In Discussions
#7
For USA, you can follow recommendations HERE. I am not sure if you would require Registration/Listing though. Any comments about registration/listing requirements, Exempt or Subject to Enforcement Discretion?
In my earlier comment I was not sure about registration/listing, but now I am sure. RUO IVDs do not require registration or listing.
 
Thread starter Similar threads Forum Replies Date
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2
J Research Use Only (RUO) for Non IVD in EU EU Medical Device Regulations 5
S Medical Device Research Use Only (RUO) label Other Medical Device Regulations World-Wide 4
H Research Use Only (RUO) Medical Devices in China China Medical Device Regulations 7
W Question on Research Use Only (RUO) products into Indonesia, Philippines and Thailand Other Medical Device Regulations World-Wide 2
H Medical Device RUO (Research Use Only) and 'Sterile' Label Claims 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Research Use Only (RUO) Medical Devices and FDA Registrar Corp 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R "RUO" (Research Use Only) Medical Device now seeking Clinic Use 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D RUO (Research Use Only - Laboratory Instrument) CE Marking Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V CE marking and RUO (Research Use Only) products - Distributing in vitro products EU Medical Device Regulations 6
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Pre-clinical Studies for RUO Product Other Medical Device Regulations World-Wide 1
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
R RUO audits - CFR 820.22 and ISO 13485 8.2.4 Internal Auditing 3
M Use of RUO reagents in an LDT Quality Manager and Management Related Issues 2
S Distribution of IVD products for RUO and IUO-FDA Final Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R MDR Reporting for event with RUO instrument 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Freeze Drying Process Control for Antibodies (RUO and IVD) ISO 13485:2016 - Medical Device Quality Management Systems 1
M Reusing existing RUO Software for IVD Development 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y Draft Guidance - IVD Products Labeled for RUO - FAQs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Can an IVD kit be used on RUO Instrument as per EU (and US) regulations? CE Marking (Conformité Européene) / CB Scheme 4
S Same computer for RUO and IVD - Same part number for 2 different IVDs EU Medical Device Regulations 2
S Any violation with the use of RUO software with IVD instrument CE Marking (Conformité Européene) / CB Scheme 3
S Single Medical Device Warranty card for both RUO and IVD!! ISO 13485:2016 - Medical Device Quality Management Systems 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
A VDmax25 and cGMP requirements for "research use only" products Other Medical Device Related Standards 1
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
M Exemption Clauses for Research, Demonstration, etc. Other Medical Device Regulations World-Wide 2
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
N Dataset for Academic Research - Infusion pump flow IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
Y Change Management in a very complex Research Organization Misc. Quality Assurance and Business Systems Related Topics 3
L EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations EU Medical Device Regulations 1
T Control of R&D (Research and Development) Parts and Equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
I AS9100D - Interview Request - I'm doing research Misc. Quality Assurance and Business Systems Related Topics 1
I Design & Development, Research and Innovation in the Medical Device framework ISO 13485:2016 - Medical Device Quality Management Systems 3
R University Research Project - Management Review Management Review Meetings and related Processes 17
F Scientific and Research Papers for Foreign Approved Devices Other US Medical Device Regulations 1
S Does a Research facility require DEA registration ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Early Research & Development - ISO 13485:2003 requirements Clarification ISO 13485:2016 - Medical Device Quality Management Systems 34
Q IEC 60601 for Non-Medical Research Purpose Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
C Selling of Research products in Europe EU Medical Device Regulations 9
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
E Research or other consents missing from the Donor Medical Chart Document Control Systems, Procedures, Forms and Templates 5
I Is ARIMA (Time Series Analysis) Model appropriate for this Dental Research? Using Minitab Software 4

Similar threads

Top Bottom