EU MDR’s Bio-compatibility Requirements for Medical Devices & ISO 10993

As a part of making the regulatory process stringent, EU MDR requires all the medical device manufacturer looking to market their devices in the European market to be have their medical devices tested robustly for bio-compatiblity. The ISO 10933 can be taken as a basic standard which provides relevant guidelines and information on the products to be bio-compatible.

The Basics of Bio-compatibility According to ISO 10933

Risks Associated with Lack of Bio-Compatibility

Several biological and non-biological risks can be associated with lack of biocompatibility in a device. The causes of these risks can be a potential source of harm once they get in contact with the human body. Some examples of these potential causative risk agents include chemicals present in the medical device which can enter inside the human body, implants which can initiate an immune response, deformed or broken materials or pieces of a medical device etc.

Important Terms and Their Definitions

ISO 10993 defines some important terms in the context of bio-compatibility. These are:

Biological Risk

Combination of the probability of harm to health occurring as a result of adverse reactions associated with the medical devices or medical interactions, and the severity of that harm.

Biological Safety

Biological safety is defined as attaining the freedom from unacceptable biological risks.

Biocompatibility

Ability of a medical device or material to perform with an appropriate host response in a specific application.

Host Response

The potential undesirable actions which the host body can show against an implant or a medical device.

Bio-compatibility and Regulatory Requirements

Regulatory bodies such as FDA, MHRA and European bodies emphasize on the medical devices to be bio-compatible.

Bio-Compatibility of Dental Implants

Regulatory Requirements and ISO 10933-1

Medical device manufacturers should reference the ISO 10933-1 as their guide to meet regulatory requirements related to bio-compatibility of medical devices. The endpoints required for evaluation of biological safety are one of the prime examples, which the manufacturers use to evaluate the information about evaluating the endpoints of medical devices which can come in contact with the human blood. These endpoints are the part of Table A.1 of the Annex A of ISO 10933-1. These endpoints include:

  • Physical or chemical information
  • Cytotoxicity
  • Sensitization
  • Irritation or intracutaneous reactivity
  • Material mediated pyrogenicity
  • Acute systemic toxicity
  • Subacute toxicity
  • Chronic toxicity
  • Implantation effects
  • Hemocompatibiity
  • Carcinogenecity
  • Reproductive or developmental toxicity
  • Degradation

Medical device manufacturers can critically evaluate their devices on the basis of these endpoints while at the same time classifying them on the basis of the nature of the body contact, they have with the living bodies and the time duration of the body contact.

ISO 10933-1 does not recommend the use of animal experiments to check the biological safety of the medical device. Instead, it urges the manufacturers to carry out material characterization of the medical device, which is not only valid in terms of data but also in ensuring high biological safety.

ISO 10933-1 also emphasizes on the biological safety of the medical device over the entire life-cycle of the device. As the standard mentions,

“The biological safety of a medical device shall be evaluated by the manufacturer over the whole life cycle of a medical device.”

(ISO 10933-1, Clause – 4.7)

In terms of biological safety, the standard says:

“The biological safety of a medical device shall be evaluated by the manufacturer over the whole life cycle of a medical device.”

(ISO 10933-1, Clause – 4.3).

Information Processing and Bio-compatibility

To evaluate the factors affecting the bio compatibility of a medical device, the manufacturers should use any available information, add any missing information, and evaluate the existing information available.

Do’s and Don’ts for the Manufacturers

The manufacturers should remember some important points:

Relying on Existing Opinions

Regarding an endpoint of bio-compatibility of a medical device, the manufacturers should not rely on the existing information and should always go for the testing methods to determine the bio-compatibility of the medical device. Relying on the existing information does not meet the MDR’s standards.

Providing Necessary Supporting Evidence

One may find some contradictory claims in ISO 10933-1 and MDR which may lead him to believe that no testing is required for certain products. In that case:

The Needs and Requirements of Notified Bodies

The manufacturers must know that the Notified Bodies require a test for each endpoint enlisted above or at least, a reason for removing or replacing the test. This automatically concludes the importance of conducting tests.

Effects Which Can Occur Due to Lack of Testing

The manufacturers must be well aware of the effects which can be posed by the residues, improper materials used in production, inadequate polymerization etc. on the human body. By discussing the hazardous effects of these, the manufacturers will be able to comprehend the aftermath of these hazardous materials on the human body.

Abstaining from the Use of Low-Quality Materials

Manufacturers can avoid a lot of problems by using standardized, approved and high-quality materials from the very start of the production process.

Managing Medical Devices Bio-Compatibility Requirements as per EU MDR

It is comprehensible that compliance management for medical device bio-compatibility require expertise and guidance of those who are already in this role. It also needs to get connected with testing facilities where those tests can be performed.

TS Q & E is a subject area specialist employing various engineers, and consultants internationally and also have connections to facilities where bio-compatibility tests can be arranged for your medical devices. You can contact us through TS Q&E Contact us form and let us know your requirements.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.