With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations.
In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
3. The Regulations, They Are a Changin’
New MDRs (May 2021 is coming)
-May 2020 deadline postponed
New 10993-18 (2020)
Recent ISO 10993-1 (2018)
Feels Recent ISO 18562 (2017)
2
4. Some MDR Pinch Points:
– There is no “grandfathering” provision
– There is an expanded definition of what is considered a medical device
– Requirement of a “Qualified Person” who is Responsible for Compliance
MDR is Postponed
May 2017
May 2020
May 2025
New MDRs Ratified
MDR Compliance
Required for New Devices
or Resubmission
All devices on market
must be MDR compliant
Devices submitted before May 2021
meet their scheduled expiration date
May 2021
3
5. MDR Remediation
• It’s all about biocompatibility
– Many devices on the market in EU were originally
determined to be biocompatible based on history
of clinical use
– Outdated and limited testing methods were used
– There are examples of patient injury because
previous level of attention/scrutiny weren’t good
enough
• We can’t say “this knee is safe because it is the
same material as that knee which has been on
the market in the EU”
4
6. 5
Meet Table A.1 from ISO 10993-1
• Issued August
2018
• Replaced 2009
version
7. ISO 10993 is intended as a
guidance to determine the
potential biological risks arising
from the use of medical
devices.
Meaning, what is the risk of my
materials and processes to the
patient?
ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process
ISO 10993 and RISK
6
8. 7
What should be included in a BEP?
• Material Characterization
• Suppliers
• Patient contact
• Specification sheets
• Testing information on raw materials
• Device description and categorization
• Include pictures
• Special Test Sample Preparations
• Master product
• Absorption capacity
• Parts to include or exclude
• Cut/don’t cut
• Testing and risk assessments
• Identify tests to perform based on risk to patient
• Include conversation of areas where there is no risk
(important if FDA asks for consideration in a particular
area that does not apply to your specific device.)
• Toxicological Risk Assessments
Biological Evaluation Plan (BEP) and Gap Assessment
9. 8
Step 2: Look at Options for Evaluations
Device with Permanent Contact
Tissue/bone
Required Endpoint for Evaluation:
• Cytotoxicity
• Sensitization
• Irritation
• Material Mediated Pyrogenicity
• Acute Systemic Tox
• Subacute/Subchronic Tox
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation
General Options to Address Risks:
• Written evaluation addressing
risk without testing
• Traditional biological tests
• Chemistry testing followed by
written evaluation
10. 9
Step 2: Look at Options for Evaluations
Device with Permanent Contact
Tissue/bone
Required Endpoint for Evaluation:
• Cytotoxicity
• Sensitization
• Irritation
• Material Mediated Pyrogenicity
• Acute Systemic Tox
• Subacute/Subchronic Tox
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation
General Options to Address Risks:
• Written evaluation addressing
risk without testing
• Traditional biological tests
• Chemistry testing followed by
written evaluation
11. 10
Step 2: Look at Options for Evaluations
Device with Permanent Contact
Tissue/bone
Required Endpoint for Evaluation:
• Cytotoxicity
• Sensitization
• Irritation
• Material Mediated Pyrogenicity
• Acute Systemic Tox
• Subacute/Subchronic Tox
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation
General Options to Address Risks:
• Written evaluation addressing
risk without testing
• Traditional biological tests
• Chemistry testing followed by
written evaluation
12. 11
Step 2: Look at Options for Evaluations
Device with Permanent Contact
Tissue/bone
Required Endpoint for Evaluation:
• Cytotoxicity
• Sensitization
• Irritation
• Material Mediated Pyrogenicity
• Acute Systemic Tox
• Subacute/Subchronic Tox
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation
General Options to Address Risks:
• Written evaluation addressing
risk without testing
• Traditional biological tests
• Chemistry testing followed by
written evaluation
13. 12
Step 2: Look at Options for Evaluations
Device with Permanent Contact
Tissue/bone
Required Endpoint for Evaluation:
• Cytotoxicity
• Sensitization
• Irritation
• Material Mediated Pyrogenicity
• Acute Systemic Tox
• Subacute/Subchronic Tox
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation
General Options to Address Risks:
• Written evaluation addressing
risk without testing
• Traditional biological tests
• Chemistry testing followed by
written evaluation
14. 13
Step 3: Family Groupings
Set of Devices:
• 4 different plate sizes
• 5 different screw sizes
• Each screw comes in two colors
• Each plate available in cpTi or
316SS
• Each plate and screw
equivalently available from 2
suppliers
• 36 line items to be considered
• 80 different possible patient
contacting configurations
Family Groupings:
• Largest plate size
• Largest screw size*
• Test cpTi and 316SS separately
• Pool plates from different
suppliers
• Colored screws can be
considered equivalent if
colored using anodization
• One or two sets of parts can
represent entire collection
16. 15
What About GSPR 10.4 “CMRs”?
CLP Annex VI
List of Chemicals
REACH
List of Chemicals
17. 16
What About GSPR 10.4 “CMRs”?
Information on CMRs Available?
YES
STEP 1: ASK INFORMATION FROM SUPPLIERS
Are CMRs Present Above 0.1% w/w?
Chemical characterization: ISO
10993-18
RISK TO PATIENT
SCREEN for CMRs, SEMI-QUANT
RESULT:
Assess per ISO 10993-17
Document Evaluation
Full digestion
Target Analysis for CMR
YES
RESULT:
Label
Information on Concentration Available?
Is CMR > 0.1% w/w?
YES NO
RESULT:
Document
Evaluation
NO
NO
Is a CMR Found Close to 0.1% w/w?
YES
NO
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