Biological Evaluation requirements per ISO 10993 - Medical Device Testing

J

jbdominguez

#1
Can I get some assistance? New issue that has come before me (most are new to me:)).

We are coming out with a product we intend to market that is a Class I Exempt medical device that is virtually identical to a product that is currently commercially available. We have reviewed ISO 10993-1:2009 and come to the conclusion that we do not need to perform a biological evaluation. We have come to this conclusion by examining Figure B.1 of Annex B in ISO 10993-1:2009 by determining that the material is the same as in an existing commercially available device and that the device has the same manufacturing, body contact and sterilization properties. The product contains a hydrogel sheet, a foam sheet with adhesive backing, and adhesive tape. Biological testing has been performed on the adhesive backing of the foam and the adhesive sheet by their respective manufacturers.

In your opinion, are we correct in determining that a biological evaluation does not need to be performed? If so, how do we show this to customers who are requesting test results?

Thanks!!
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Need Medical Device Testing?

We have reviewed ISO 10993-1:2009 and come to the conclusion that we do not need to perform a biological evaluation. We have come to this conclusion by examining Figure B.1 of Annex B in ISO 10993-1:2009 by determining that the material is the same as in an existing commercially available device and that the device has the same manufacturing, body contact and sterilization properties. (...) In your opinion, are we correct in determining that a biological evaluation does not need to be performed?


Implicit in the ISO 10993 decision process is that the "material is the same" statement is objectively provable (i.e. same material type, same detailed formulation particularly including secondary constituents, processing contaminants/byproducts. colorants, etc., generally same vendor/formulator/grade description), you are in possession of the prior-product biocompatibility data for the "same" material, and that data does in fact demonstrate biocompatibility.

You would not be able to market without your own biocompatibility testing if the material is the "same" only in regard to its top-level descriptor (i.e. their product is made of polycarbonate, our product is made of polycarbonate), or if some aspect of their testing is inapplicable to your product, or if the manufacturer has told you the material is biocompatible but you don't have the data.

If so, how do we show this to customers who are requesting test results?

The same as if you had conducted the testing...you will have applicable data in your tech file, whatever path applied to the sourcing of that data.
 
E

Eggsn

#3
Re: Need Medical Device Testing?

From what I know about hydrogels, each manufacturers do their own formulation and it's very difficult to prove they are the same unless they came from the same supplier. Biocompatibility matters not only through each component level but also through looking at the device as a whole (i.e. manufactured finished product).

If you still come to the conclusion that you do not need testing, then ensure that this is filed and written up to show your auditors or your customers. The written justification should come with technical specs demonstrating similarity, etc. and coming/signed off by a qualified person.

Since your pads are most likely for skin use, biocompatibility testing isn't really that difficult to get. It's just a matter of time, money, and a few samples. It is sometimes easier to put these types of things to bed specially if you're dealing with many customers asking for them. If you do decide to test, I strongly suggest to test the hydrogel separately if you plan on doing certain testing like for cytotoxicity as hydrogels tend to interfere with the test methods normally used and cause a false negative result.

Hope that helps.
 
Thread starter Similar threads Forum Replies Date
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
Gamula CFDA Biological Evaluation Report China Medical Device Regulations 2
S IV Catheter Biological Evaluation - EtO Residuals - Permanent Contact Definition Qualification and Validation (including 21 CFR Part 11) 2
W ISO 10993 (Biological Evaluation of Medical Devices) for Suppliers Other ISO and International Standards and European Regulations 8
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
M Informational US FDA paper – Biological Responses to Metal Implants Medical Device and FDA Regulations and Standards News 0
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1
B Self Contained Biological Indicators as internal PCD Other Medical Device Related Standards 2
M Biological Monitoring Program Environmental Bioburden Test Method Needed ISO 13485:2016 - Medical Device Quality Management Systems 1
B Number of Biological Indicators for Routine Monitoring of ETO Sterilization Cycle Other Medical Device Regulations World-Wide 8
J ISO 10993 (Biological Compatibility) Approved Materials US Food and Drug Administration (FDA) 23
S Requirements of USP24 NF18 1995 for the Biological Test for Plastics Other Medical Device and Orthopedic Related Topics 3
M Biological Indicator Ethylene Oxide Sterilization Other Medical Device and Orthopedic Related Topics 11
D MDD 2007/ - Essential Requirement Checklist - Physical and Biological Properties EU Medical Device Regulations 4
I Glass Packaging Material (Jars) - Chemical, Physical and Biological Controls Manufacturing and Related Processes 1
tsmith7858 How to treat something (biological hazard) you know is there... Food Safety - ISO 22000, HACCP (21 CFR 120) 7
J Effects of substrate on biological indicator organisms US Food and Drug Administration (FDA) 2
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 2
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
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
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
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
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
T HF testing / Summative evaluation for MDDS class I necessary? Human Factors and Ergonomics in Engineering 2
N Evaluation of service providers Supplier Quality Assurance and other Supplier Issues 2
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 2
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 12
C Material from outside CER evaluation period CE Marking (Conformité Européene) / CB Scheme 8
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
P SOUP anomaly evaluation for MMA IEC 62304 - Medical Device Software Life Cycle Processes 2
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 9
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
R Supplier evaluation and business needs in the context of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
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
K Supplier re-evaluation (API Q1) Manufacturing and Related Processes 8
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
qualprod ISO 9001 Clause 9.1 - Monitoring measurement analysis and evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
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 US – National Evaluation System for Health Technology Coordinating Center (NESTcc) Solicits Public Comments for Data Quality and Methods Frameworks Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom