Catch Me If You Can: �The Hide 'n Seek of Biocompatibility

Marina Daineko

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August 15^th, 2024

“There are … things that will destroy us: �politics without principle; �knowledge without character and �business without ethics”� Ghandi

Biocompatibility Evaluation using PMS

Biological Evaluation is conducted within a total life cycle

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I recommend to review Biological Evaluation whenever new relevant post-market information can impact biological safety

Biocompatibility Evaluation using PMS

Biological Evaluation is conducted within a total life cycle

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I recommend to review Biological Evaluation whenever new relevant post-market information can impact biological safety

Updates to ISO 10993-1

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We need to analyze

• patient feedback
• other post-market information relevant to biological safety

Step 1 – Collect information

Trends in Adverse Events

Sources of information can be different

Biocompatibility hazards shall be reviewed

New Information

New information may become available for other relevant medical devices or materials

Scientific Literature Review

Information related to test results assessment, �Scientific Opinions �on chemicals…

Step 1 – Hoodin application

Step 2 – Decode the data

This picture is designed to give the viewer the simulated experience of having a stroke (particularly in the occipital lobe of the cerebral cortex, where visual perception occurs)

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Everything looks hauntingly familiar, but you just can't quite recognize anything

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Step 2a – EDs and CMRs

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) -Regulation (EC) No 1907/2006 

Endocrine disruptor (ED)

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Classification, Labelling and Packaging (CLP) -Regulation (EC) No 1272/2008

Carcinogenic, Mutagenic or toxic to Reproduction (CMR)

• Category 1A: known to be CMR -human data; 
• Category 1B presumed to be CMR -animal data and 
• Category 2: suspected to be CMR -with limited human and animal data.

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Step 2a - EU MDR requirements

REACH

(ED)

CLP

(CMR)

MDR

Devices shall only contain CMR 1A and 1B and EDs above 0.1% w/w if justification is provided:

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• invasive and come into direct contact with the human body, 
• (re)administer medicines, body liquids or other substances, including gases, to/from the body, or 
• transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body

MDR, Annex I, Chapter II, 10.4.1. Design and manufacture of devices https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745

Step 2b – Adverse events related to competitor’s device

1. Identify whether these events relate to biological safety
2. Sit down together with cross functional team and
3. Go through risk management process to identify risk measures

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It means you might want to

• change something in your medical device (e.g. material) or
• perform additional investigation to make sure that there is no additional risk there

Step 2c – Adverse events related to your device

To properly review the sales and complaints data, do the following:

1. Review only the ‘No malfunction based on complaint information’ or ‘Malfunction code cannot be determined’ malfunction codes (or their equivalents)

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• Review only the harm codes that are considered biological responses, i.e.:
• Allergic reaction
• Localized rash or irritation
• Toxicity
• Cardiovascular factors
• Ingestion factors

If you consider the probability of occurrence for each harm code as LOW RISK per the established SOP, no further investigation is required

MODERATE and HIGH RISKS associated with biological hazards require additional investigation which may include additional testing beyond what is recommended in ISO 10993-1

Step 3 – Update your BE

State whether medical devices are

SAFE or NOT SAFE

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for the labeled and intended use!

Key take away

If you want to sell safe device, stay compliant and keep the business rolling �I recommend you the following:

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• use tools like Hoodin to gather the information
• analyze the post market data (reach out to specialists of the same level as me)
• update the BER when required

Thank you!

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Feel free to get in touch!

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mdaineko@intrinsicmedicalgroup.com

https://www.intrinsicmedicalgroup.com