Biocompatibility Tests

EUROLAB How can it help you comply with the new MDR?

If you need help understanding the requirements or would like someone to help conduct a gap analysis for current compliance as you plan your MDR migration strategy, EUROLABhas a team of expert advisors and a process 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. Below to help you address MDR EUROLABHere is an example of the services available to:

Gap analysis

Evaluate changes in regulatory standards where previous testing was conducted against the most recent regulatory standards.

• Review of each standard for which previous tests were carried out and new standards that may now apply to the device
• Review of final test reports made before
• Recommend tests that should conform to the most current standards

0.1% Carcinogenic, mutagenic or toxic to reproduction (CMR) and endocrine disruptors: 

One of the requirements in the MDR is under section 10.4.2. Justification for the presence of CMR and / or endocrine disruptors at a concentration above 0, 1% by weight (w / w). In this section the regulation describes the justification process for carcinogens, mutagens or reproductive toxic substances (CMR) or endocrine disruptors. This justification should include consideration of:

• Analysis and estimation of potential patient exposure to the CMR substance
• Analysis of possible alternative materials or designs
• Analysis of protecting proper device function and usage benefit.

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

• Request composition descriptions from the supplier, which includes compounds and amounts of compounds found in the material. This information is used to determine the percentage per weight in the device.
• If composition information is not available from the material supplier, an aggressive chemical analysis can be used to fill the gaps. This analysis will identify and quantify compounds that can be considered as CMR or endocrine disruptors.

Standard Biocompatibility Approach:

Today's complex device manufacturers must evaluate the biocompatibility of medical device materials and processes using a holistic risk-based approach to biological safety assessments.

Our experts divided the biological safety assessment process into three distinct stages that can be used to host a medical device at any stage of the product lifecycle:

STEP 1: Creating a Biological Assessment Plan (BEP); consider the device materials, intended use, and available data to establish a risk-based approach to assessing device safety.

STEP 2: Conduct Biological Assessment; 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 Assessment Report (BER);  Interprets BEP and biological assessment findings in a single report. EUROLABWritten by 's expert evaluators, this information is a summary of all the evidence collected to support the biological safety of the device.

Understanding these new regulations and preparing to meet them is no small undertaking. Because EUROLABThe expert consultants at are ready to help you understand your testing needs and get your products certified and safe to patients who need them. We are ready to help you create a gap analysis and a clear strategy to meet this new MDR.

EUROLAB, with its highly expert team and internationally accredited laboratories, Biocompatibility Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.