A Delay in MDR: Where are We Now
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The document discusses delays and compliance requirements related to the Medical Device Regulation (MDR), highlighting the need for updated biocompatibility evaluations and the absence of grandfathering provisions. It emphasizes the importance of a Biological Evaluation Plan (BEP) that includes material characterization, testing, and risk assessments for devices. Additionally, it outlines the evaluation requirements for devices with permanent tissue contact, detailing necessary endpoints and risk management strategies.
A Delay in MDR: Where are We Now
- 1. A delay in MDR? Where are we now? Thor Rollins B.S. RM(NRCM)
- 2. MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE ALWAYS AHEAD OF THE GAME. © Copyright 2020 by Greenlight Guru
- 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– Many devices on the market in EU were originally determined to be biocompatible based on history of clinical use – Outdated and limited testing methods were used – There are examples of patient injury because previous level of attention/scrutiny weren’t good enough • We can’t say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
- 15. 14 What About GSPR 10.4 “CMRs”?
- 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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- 19. QUESTIONS? 18 Thor Rollins B.S. RM(NRCM) trollins@nelsonlabs.com