Clinical Evaluation of IVD Medical Devices

E

esh14

#1
Hi All,

I have a few questions regarding the Clinical Evaluation for an IVD medical device. Can anybody help me on the questions below?

1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?

2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?

3. We intend to get CE marking for our IVD medical device.
a) In this case, can we adopt the CLSI standards in our validation protocols even though we are not going to sell our device to US market?

b) Is there any other harmonized standards or guidance document that we can refer to for our verification & validation protocols?

Much appreciated if someone could help me on this. :)
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#3
1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?
No, it only applies to the MDD and AIMDD directives.

2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?
There's at least 3 documents on performance evaluation on IVDs created by GHTF - http://www.imdrf.org/documents/doc-ghtf-sg5.asp

There also EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices

3. We intend to get CE marking for our IVD medical device.
a) In this case, can we adopt the CLSI standards in our validation protocols even though we are not going to sell our device to US market?
For the directives, you can apply anything you want. However, to gain presumption of conformity, if need to apply harmonized standards (in this case, the mentioned EN 13612:2002. If you don't, things may still be acceptable, but you won't get presumption of conformity).

b) Is there any other harmonized standards or guidance document that we can refer to for our verification & validation protocols?
Depending on the device, there may be specific documents.
 

Gert Sorensen

Forum Moderator
Moderator
#4
Hi All,
1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?
No, it specifically excludes IVD's.

Hi All,
2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?
FDA normally doesn't require clinical trials, but they have various guidance documents on their website in case you need them. Besides they accept the GHTF (IMDRF) guides.
 

pkost

Trusted Information Resource
#5
IVD's are not my area of specialism, however I will give it a go:

1. I would say that the meddev is not directly applicable, from a search of the directive "clinical evaluation" does not appear in the text, only performance validation; I'm not entirely clear on the use of a clinical evaluation of an IVD product.

2. sorry, I don't know

3. In the EU you can use any standard - be it internationally recognised or an internal standard. You just have to demonstrate how that standard supports you in meeting the Essential requirements

4. Harmonised standards for the IVD directive can be found here: http://ec.europa.eu/growth/single-m...ds/iv-diagnostic-medical-devices/index_en.htm

Having a quick look at the list (and without knowing exactly what you are looking for) you may be interested in EN 13612, EN ISO 20776-1, EN ISO 23640
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Be sure to classify your device correctly according to the IVD directive. You might be exceeding the actual requirements.
 
E

esh14

#7
Be sure to classify your device correctly according to the IVD directive. You might be exceeding the actual requirements.
We understand that the CLSI consensus standards are more detailed and more stringent compared to EU harmonized standards.

We referred to the CLSI consensus standards in our protocols as initially US is the first target market for our product. However, we have changed our plan and decided to get CE marking for our product first before we release our products to other countries.

Thus, I'd like to know if we should prepare two separate sets of clinical performance study protocols and records for EU & US FDA submission. May I know whats the usual industry practice in the market?

Your advise is greatly appreciated.
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#8
FDA normally doesn't require clinical trials,
Please note that clinical evaluation is not clinical trial. Clinical trials may be used as part of clinical evaluation (I do think that the requirements for clinical evaluation / performance evaluation in the directives are the best ones related to clinical data).

1. I would say that the meddev is not directly applicable, from a search of the directive "clinical evaluation" does not appear in the text, only performance validation; I'm not entirely clear on the use of a clinical evaluation of an IVD product.
"Performance evaluation" is more or less "clinical evaluation" for IVDs (because it does not rely on clinical data, but on performance data). You can check the difference in some GHTF documents at http://www.imdrf.org/documents/doc-ghtf-sg5.asp

You might be exceeding the actual requirements.
I usually prefer to focus on doing the right thing instead of only basing on the "actual"requirements (which are generally only a part of the you should do, because, as requirements, they usually are written in a way that they focus the expectations in only a few words).. This is in my opinion of of the worst problems we have right now in RA, because a lot of manufacturers who does not know the basics of what they do (I'm not saying this is the case here) simply try to do do as low as possible to only meet the requirements. Then, when the expectations and thus the requirements changes, they are at a loss.

Anyway, you are right in mentioning this, because if the device is not on the lists of Annex II, performance evaluation is not expected.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Anyway, you are right in mentioning this, because if the device is not on the lists of Annex II, performance evaluation is not expected.
This is what I was referring to.

Similarly, no point applying class III requirements to a class I medical device. That's the whole point of classification.
 
Thread starter Similar threads Forum Replies Date
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 19
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 1
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 12
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 0
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 0
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
M CER (Clinical Evaluation Reports) updates - Product Codes EU Medical Device Regulations 2
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
W Literature used in the clinical evaluation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 10
M SOPs, Plans and Report templates for Clinical Evaluation of EU MDR Other Medical Device Related Standards 7
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
TheMightyWife Copyright for articles used in CER (Clinical Evaluation Report) EU Medical Device Regulations 16
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
Rincewind Clinical Evaluation of very low risk medical devices EU Medical Device Regulations 3
SK13485 Can a literature alone be used for the purpose of Clinical Evaluation of a device? EU Medical Device Regulations 6
R Scope and plan of the clinical Evaluation CE Marking (Conformité Européene) / CB Scheme 3
M MDR Clinical Evaluation & investigation (SUMMARY of changes) EU Medical Device Regulations 2
R Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template EU Medical Device Regulations 4
M Clinical Evaluation - MEDDEV 2.7/1 rev4 - Literature route Other Medical Device Related Standards 2
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
Q Sample of the MEDDEV 2.7.1 rev 4 Clinical Evaluation Report wanted Document Control Systems, Procedures, Forms and Templates 15
Sam Lazzara Clinical Evaluation MEDDEV Guidelines SmackDown - 2017 EU Medical Device Regulations 3
L Clinical Evaluation Report Updating Procedure Other Medical Device Related Standards 5
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
R Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template ISO 13485:2016 - Medical Device Quality Management Systems 6
Z Labeling Requirements for Free Samples supporting Clinical Evaluation EU Medical Device Regulations 2
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
shimonv CFDA Technical Guidelines for Clinical Evaluation on Medical Devices (English) China Medical Device Regulations 8
S Clinical evaluation standard operating procedure / SOP for medical devices Document Control Systems, Procedures, Forms and Templates 1
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 11
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
M Clinical Evidence - Clinical Evaluation Report for Class I medical devices EU Medical Device Regulations 1
P What to include in a Clinical Evaluation Plan EU Medical Device Regulations 2
R FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies Other US Medical Device Regulations 3
M Clinical Evaluation sample for X-Ray Machine CE Marking (Conformité Européene) / CB Scheme 1
T Unnecessary Modification Clinical Evaluation 510(k) Other US Medical Device Regulations 2
F MDD, Technical File, Clinical Evaluation for PACS/DICOM Viewer ISO 13485:2016 - Medical Device Quality Management Systems 2
Similar threads


















































Top Bottom