Is fabric biocompatibility the same as medical device conformity?

The problem: the right document, the wrong question

Purchasing and quality teams in healthcare often face the same situation: a supplier presents a biocompatibility report for a fabric, and the report is taken as proof that the product is suitable for medical use. The report may be genuine and valid. The problem is that the question it answers is not the question the purchasing team is asking.

This confusion is not limited to hospitals. Home and hotel textiles, medical devices and personal protective equipment (PPE) are subject to different rules and cannot be presented at the same conformity level.

The frame: biocompatibility is a test, conformity is a process

Biocompatibility is the examination, with defined methods, of whether a material causes unwanted biological effects in contact with the body. For medical devices, this assessment is usually based on the ISO 10993 series. A biocompatibility report covers the material tested, the method applied and the type of contact assumed.

Medical device conformity is a much broader process. In the EU, the framework is set by Regulation (EU) 2017/745 on medical devices. The product class, intended purpose, risk management, technical documentation, clinical evaluation and, where the class requires it, assessment by a notified body are all part of this process. Biocompatibility data is only one component of that file.

For PPE, the framework is separate: Regulation (EU) 2016/425 on personal protective equipment and the relevant harmonised standards for the product category. The conformity of a protective garment comes not from the biocompatibility of its fabric, but from verifying its defined protective performance against the relevant standard.

Separating the layers of documents

A textile product is surrounded by documents at different levels, and each shows only its own scope:

• Organisation: quality, environmental or occupational health and safety management system certificates. They show how the manufacturer manages its processes; they are not proof of product performance.

• Production site: environmental studies for a specific site and period.

• Raw material: supply documents issued for a specific raw material and its producer. They cannot be used as a certificate for the finished product.

• Fabric: biocompatibility or harmful-substance tests. They are tied to the fabric code tested and do not automatically cover the whole product or its packaging.

• Product: performance and environmental studies for a specific product, sample and system boundary.

• Regulatory conformity: the CE process for a medical device or PPE, tied to the product class and the technical documentation.

A document on one layer does not answer the question of another layer. A test carried out on a fabric does not automatically cover every SKU made from that fabric, or every area of use.

Questions to ask when reading a report

When you receive a biocompatibility report, check the following:

1. What exactly is the material tested? Are the fabric code, composition and sample details stated in the report?

2. Which method and standard were applied?

3. Which type of contact and area of use does the report assume?

4. Are the report number, date and issuing laboratory stated?

5. Is the product offered the same as the material tested, or has there been a change in composition or process in between?

The regulatory status of the product needs separate questions: in which class is the product assessed? Is the conformity process complete, or still in progress? Which model code does the CE marking cover?

Starting a process is not certification

The fact that a conformity assessment process has started does not mean the product's conformity is complete. Until the process is complete, the correct wording is "conformity assessment in progress", and the CE marking is not used at this stage. A status that is still in progress should not be displayed in the same way as a completed certificate either.

How NEWSOUL approaches it

NEWSOUL keeps the layers of documents apart:

• Biocompatibility data is shared per product and limited to the material tested, the method and the area of use; a fabric test is never extended to the whole product family.

• Organisation certificates are not presented as product evidence, and raw-material documents are not shown as finished-product certificates.

• No product whose conformity process is incomplete carries the CE marking or a statement of completed conformity.

• Products within the scope of medical device or PPE rules are not offered for sale until their conformity scope is complete.

• For healthcare products, dimensions, use model and regulatory class are confirmed per product.

The limit: what this guide does not say

This article is a general framework. It is not legal advice, nor a declaration of conformity for any particular product. The biocompatibility scope and regulatory status of a product are communicated per product, together with its class and the relevant reports.

Next step

To find out about a product's biocompatibility report, test scope or regulatory status, choose "Technical information" in the request form. Telling us your area of use and the type of contact helps us send you the right document.