A delay in MDR?

Where are we
now?
Thor Rollins B.S. RM(NRCM)
 MEDICAL DEVICE QUALITY IS ALL WE DO,
AND WE’RE ALWAYS AHEAD OF THE GAME.

© Copyright 2020 by Greenlight Guru

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
 MDR is Postponed
MDR Compliance
Required for New Devices
May 2017 May 2025
or Resubmission

All devices on market

New MDRs Ratified May 2020 must be MDR compliant
May 2021
Devices submitted before May 2021
meet their scheduled expiration date
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

3
 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– Outdated and limited testing methods were used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
Meet Table A.1 from ISO 10993-1

• Issued August
2018

• Replaced 2009
version

5
ISO 10993 and RISK

ISO 10993 is intended as a

guidance to determine the Meaning, what is the risk of my
potential biological risks arising materials and processes to the
from the use of medical patient?
devices.

ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and

testing within a risk management process

6
 Biological Evaluation Plan (BEP) and Gap Assessment
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

7
Step 2: Look at Options for Evaluations

Device with Permanent Contact

Tissue/bone

Required Endpoint for Evaluation:

• Cytotoxicity
General Options to Address Risks:
• Sensitization
• Written evaluation addressing
• Irritation
risk without testing
• Material Mediated Pyrogenicity
• Traditional biological tests
• Acute Systemic Tox
• Chemistry testing followed by
• Subacute/Subchronic Tox
written evaluation
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation

8
Step 2: Look at Options for Evaluations

Device with Permanent Contact

Tissue/bone

Required Endpoint for Evaluation:

• Cytotoxicity
General Options to Address Risks:
• Sensitization
• Written evaluation addressing
• Irritation
risk without testing
• Material Mediated Pyrogenicity
• Traditional biological tests
• Acute Systemic Tox
• Chemistry testing followed by
• Subacute/Subchronic Tox
written evaluation
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation

9
Step 2: Look at Options for Evaluations

Device with Permanent Contact

Tissue/bone

Required Endpoint for Evaluation:

• Cytotoxicity
General Options to Address Risks:
• Sensitization
• Written evaluation addressing
• Irritation
risk without testing
• Material Mediated Pyrogenicity
• Traditional biological tests
• Acute Systemic Tox
• Chemistry testing followed by
• Subacute/Subchronic Tox
written evaluation
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation

10
Step 2: Look at Options for Evaluations

Device with Permanent Contact

Tissue/bone

Required Endpoint for Evaluation:

• Cytotoxicity
General Options to Address Risks:
• Sensitization
• Written evaluation addressing
• Irritation
risk without testing
• Material Mediated Pyrogenicity
• Traditional biological tests
• Acute Systemic Tox
• Chemistry testing followed by
• Subacute/Subchronic Tox
written evaluation
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation

11
Step 2: Look at Options for Evaluations

Device with Permanent Contact

Tissue/bone

Required Endpoint for Evaluation:

• Cytotoxicity
General Options to Address Risks:
• Sensitization
• Written evaluation addressing
• Irritation
risk without testing
• Material Mediated Pyrogenicity
• Traditional biological tests
• Acute Systemic Tox
• Chemistry testing followed by
• Subacute/Subchronic Tox
written evaluation
• Chronic Tox
• Genotox
• Carcinogenicity
• Implantation

12
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
13
What About GSPR 10.4 “CMRs”?

14
What About GSPR 10.4 “CMRs”?

CLP Annex VI
List of Chemicals

REACH
List of Chemicals

15
 What About GSPR 10.4 “CMRs”? STEP 1: ASK INFORMATION FROM SUPPLIERS
Are CMRs Present Above 0.1% w/w?

YES Information on CMRs Available?

Information on Concentration Available?
NO
NO Chemical characterization: ISO
YES 10993-18
Full digestion
Is CMR > 0.1% w/w? Target Analysis for CMR RISK TO PATIENT
SCREEN for CMRs, SEMI-QUANT
YES
Is a CMR Found Close to 0.1% w/w?
YES NO
RESULT: RESULT: NO
Label Document
RESULT:
Evaluation
Assess per ISO 10993-17
Document Evaluation

16
For More Educational Events & Resources Visit:

Expert Lab Testing & Advisory Services
Industry-leading provider of global lab testing
and expert consulting services. We perform
microbiological and analytical laboratory tests
across the medical device, pharmaceutical, and
tissue industries.
www.nelsonlabs.com/education
Sales@nelsonlabs.com
+1 801-232-6293
Comprehensive Sterilization Solutions & Expert
Advisory Services
Global leader in comprehensive sterilization
solutions and advisory services. We have deep
expertise across Gamma, EO, NO2, E-Beam and
X-Ray sterilization for multiple industries
including medical device and pharmaceutical. Our
operations span 45 facilities in 13 countries.
www.Sterigenics.com/resources
+1 800-472-4508

Webinars Videos Open Houses Articles

Seminars Whitepapers Trade Shows
 QUESTIONS?

Thor Rollins B.S. RM(NRCM)

trollins@nelsonlabs.com

18