BIOCOMPATIBILITY IN EU MDR &

ISO10993-1:2018
 Difference between MDD & MDR
MDD MDR
Focus on compatibility of materials on biological Focus on compatibility of materials and substances
tissues, cells and body fluids on biological tissues, cells and body fluids
No specific mention Aspects of absorption, distribution, metabolism and
excretion of substances and materials
Mentions CMR substances without any limit. Mentions CMR substances and endocrine disrupting
Phthalate was of focus substances with a level of 0.1%w/w.
So both qualitative and quantitative data is required
No specific mention Impact of processes on material properties
No specific mention Reduce risks as far as possible from substances and
particles emerging from wear debris, degradation
products and processing residues
No specific mention Evaluate the risks due to the size and properties of
particles which can be released into the patient or
user's body
 ISO10993-1:2018 and MDR
• The ISO10993-1:2018 requirements can be used to comply to the MDR
• The following areas are changed in the 2018 version:

Scope

Principles

End-points

Categories
ISO10993-1:2018 - Scope
Biological evaluation now includes not just devices which contact the patient,
but also devices that contact the user for the purpose of providing protection.
For example, gloves and masks. Risks due to breakage or mechanical failure
now are under the scope of the standard. So, such situations also need an
evaluation for biological risks.
ISO10993-1:2018 - Principles
• Instead of tests, the standard now refers to endpoints. Tests to be conducted
after a risk assessment of the material with respect to the endpoint
• Manufacturers to consider the effect of the packaging materials which come in
direct or indirect contact with the device.
• Biological evaluation needs to be done for the whole lifecycle of the medical
device is new. This may need a biological evaluation at the end of shelf-life.
• For reusable devices, the manufacturer must evaluate the biological safety of
the medical device for the maximum validated cycles of reuse.
 ISO1093-1:2018 - Endpoints
• Additional endpoints such as material mediated pyrogenicity and sub-acute
toxicity, carcinogenicity, reproductive toxicity and degradation added
• Some types of devices need additional endpoints in comparison to the earlier
standard.
 ISO10993-1:2018 - Categories
• A new category called 'transient' devices has been introduced. This is
applicable for devices like needles and surgical blades, which are in contact for
less than a minute. For such devices there is no more a need to do testing,
unless coatings or lubricants are used.
• The contact duration of 'permanent' has been changed to 'long term', which
includes both implants and other long-term devices.
• Categorization of gas pathway device components with only indirect contact,
shall be based on ISO 18562
ISO10993-1:2018 – Physical & Chemical Information
• The standard has now added physical and chemical information as a
prerequisite before doing a biological safety assessment
• There are 3 ways of getting this information
Supplier Information

Predicate Testing

Material Characterization
 Definitions
• Physical and chemical information
knowledge regarding formulation, manufacturing processes, geometric and
physical properties and type of body contact and clinical use that is used to
determine whether any additional biological or material characterization testing
is needed
• Material characterization
broad and general process of collecting existing information about a material’s
chemistry, structure and other properties, and if appropriate, new data, to
facilitate the evaluation of these properties
 Biological Evaluation as per ISO10993-1:2018

Biological Evaluation Plan:

what are your risks and how Biological Evaluation Report:
do you plan to mitigate them Testing and risk assessments
is the device safe
 Summary of the process

Identify materials and substances

Evaluate impact of
Identify whether Evaluate the Evaluate the wear debris,
Evaluate risks of Evaluate impact of
there are any CMR or impact of impact of leachable &
nano particles if device physical
ED substances > 0.1% packaging & manufacturing degradation
present characteristics
w/w ageing processes products and
processing residues

Evaluation of above risks to consider the biological

endpoints given in table A1 of ISO10993-1:2018