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Biocompatibility

How can Nelson Labs Help You Comply with the new MDR?

As you plan your MDR transition strategy, if you need help understanding the requirements, or want someone to help conduct a gap analysis of your current readiness for compliance, Nelson Labs has a team of expert advisors and a process available to help manufacturers bring their devices into compliance with the new MDR. The details of the evaluation process will depend on the number and range of devices being evaluated and their clinical use history. Following is a sampling of the services that Nelson Labs can employ to help you address the MDR:

Gap Analysis:

Evaluate changes in regulatory standards under which previous testing was performed compared to the most current regulatory standards.

  • Review of each standard under which previous testing was performed and new standards that may now apply to the device.
  • Review of final test reports performed previously
  • Recommend any testing needed to be in compliance with the most current standards

 

0.1% Carcinogenic, mutagenic, or toxic to reproduction (CMR) and endocrine disrupting substances: One of the requirements in the MDR is under section 10.4.2 Justification regarding the presence of CMR and/or endocrine-disrupting substances in a concentration above 0,1 % weight by weight (w/w). In this section the regulation spells out the justification process for carcinogens, mutagens, or reproductive toxic substances (CMR) or endocrine-disrupting substances. This justification should include consideration of the following:

  • Analysis and estimation of potential patient exposure to the CMR substance
  • Analysis of possible alternate materials or designs
  • Analysis of maintaining proper device function and benefit of use.

From here, the manufacturer will proceed with one of the two following steps:

  1. Request composition disclosures from the supplier which include the compounds and amount of compounds contained in the material. This information is used to determine the percentage amount per weight in the device.
  2. If composition information is not available from the material supplier, an aggressive chemical analysis can be used to fill in gaps. This analysis will identify and quantify compounds that may be considered CMR or endocrine-disrupting.

 

Standard Biocompatibility Approach:

Manufacturers of modern-day, complex devices need to assess the biocompatibility of their medical device materials and processes by taking a holistic risk-based approach to their biological safety evaluations.

Figure 2. A three-phase approach to evaluating the biocompatibility of a medical device.

Our experts have broken out the biological safety evaluation process into three distinct phases that can be used to accommodate a medical device in any stage of the product life cycle:

STEP 1: Create a Biological Evaluation Plan (BEP); consider the device materials, intended use, and existing data to prescribe a risk-based approach to the evaluation of device safety.

STEP 2: Execute the Biological Evaluation; based on the risks identified in the BEP, perform a combination of analytical chemistry testing, biocompatibility testing and assessment, and toxicological risk assessment.

STEP 3: Make a Biological Evaluation Report (BER); interpret the BEP and the findings of the biological evaluation into one report. Written by Nelson Labs’ expert assessors, this information is a summary of all the evidence gathered to support the biological safety of the device.

Understanding these new regulations and getting prepared to meet them is no small undertaking. That is why the expert advisors at Nelson Labs are ready to help you understand your testing needs and get your products certified and safely to those patients who need them.

This on-demand webinar walks through a real-life example of bringing a device that has been on the market in Europe into compliance with the ISO 10993 and the new MDR.

Let us help you create a gap analysis and a clear strategy for meeting these new MDR.

Call us today at (801) 290-7500 or email us at advisoryservices@nelsonlabs.com