Medical devices - Chemical tests of medical devices

As a professional in the field of medical equipment or pharmaceutical products, it is necessary that you have an overview of the extensive regulations and strict requirements relating to product safety and documentation.

Due to the abundance of requirements, manufacturers sometimes find it difficult to handle all parts of an approval process, e.g., the chemical characterisation of a medical device. However, this is exactly where we can help you.

At Danish Technological Institute you will be in direct contact with one of our specialists within medical devices, and you can always be sure to obtain expert advice and sparring.

No matter what kind of help you need - new ideas for your development process, chemical analyses of an existing product, or if your new products need approval – we are always ready to help you.

How can Danish Technological Institute help you?

Our accredited chemical laboratory in Aarhus (Chemical Characterisation and Services) can help you with the chemical characterisation of your medical device. We can manage all parts of a characterisation process, e.g., extractable or leakage studies, or analyses of constituents according to EN ISO 10993-18:2020.

We carry out analyses for residue solvents, residue monomers, metals, or screening analyses for unknown organic or inorganic constituents in your product.

If you need to develop new analysis methods, a co-operation with our experts will ensure that you obtain the result you are looking for.

The study or analysis results from our laboratory can for instance be used in connection with a biological assessment of your medical device. If you need a risk assessment, then you can benefit from our cooperation with toxicologists.

What is a medical device?

Medical devices comprise a wide range of products straight from most household products such as adhesive plasters, glasses, or thermometers to advanced medical apparatuses as for instance MR scanners or pacemakers.

Medical devices are intended by the manufacturer to be used for human beings for medical purposes: monitoring, prevention, treatment, or diagnosis.

The legislative framework of the medical device

All medical devices are subject to several requirements to ensure a high level of safety and performance of the device - no matter if glasses, adhesive plasters, or the screws in your body are in question. In Europe, the EU Medical Device Regulation (MDR) 2017/745 (MDR) applies to medical devices, and in the USA, medical devices are regulated by the Food and Drug Administration (FDA) and several laws apply.

How strict the requirements are for specific products depends on the risk level of the product. In the EU Directive, medical devices are made up of four risk categories, whereas FDA only has three corresponding risk categories. 

According to MDR, the four categories are: 

Class I – Low risk, e.g., glasses, adhesive plasters, or wheelchairs.

Class IIa – Average risk, e.g., syringes, or hearing aids.

Class IIb – Average risk, e.g., infusion pumps, contact lenses, or respirators.

Class III – High-risk, e.g., breast implants, or pacemakers.

Rules concerning the placing on the market

To be placed on the market, medical devices must be CE marked according to the legislation of the specific country.

Medical devices to be sold on the Union market must meet the applicable requirements of MDR 2017/745. A so-called notified body grants a CE certificate.

The notified body or authority assesses if the medical device can be approved and CE marked in accordance with a biological risk management assessment prepared by the manufacturer.

In the US, FDA is responsible for approving and CE marking medical devices. In other countries, for instance Asia or South America, other bodies approve and CE mark medical devices.

What is a biological risk assessment?

A biological risk assessment of a medical device is a systematic process used to identify, evaluate, and control potential biological risks associated with the use of a medical device.

The objective is to ensure the safe use of the medical device. Therefore, the risk of hazardous biological reactions such as toxicity, irritation, or sensitization should preferably not be present.

A biological risk assessment is important as it ensures the safe use of a device. The process covers the identification of materials, the analysis of existing data, chemical and biological analyses and evaluation, and a risk analysis in accordance with the ISO 10993 standards.

Why is chemical characterisation important for the approval of medical equipment?

A biological risk assessment of a product must be available before a medical device can be approved for placing on the market. To prepare such a risk assessment, it is necessary to know which chemical substances a consumer can be exposed to when using the product.

In some cases, the manufacturer can easily obtain the necessary information about the chemical substances in the materials that form part of the production process. In other cases, it is not possible. Whether the manufacturer has the information or not it can still be difficult to predict which chemical substances the user is actually exposed to when using the product.

In order to make a correct assessment of product safety, it is often necessary to test which chemical substances can be emitted from the medical device during use. A chemical characterisation will analyse all product parts for potential risks of possible pollution from substances that exist in or are emitted from the device. That takes place by simulating real-life conditions under which the medical device is used.

Therefore, a chemical characterisation makes sure that products are safe for users or patients in the short- as well as the long-term by certifying that they comply with legislation and consequently can obtain a CE mark and approval.

When is chemical characterisation necessary?

Chemical characterisation often serves as the basis of a biological risk assessment of a medical device. However, in some cases chemical characterisation is not necessary.  That is the case, when the manufacturer can assess and justify that he has the necessary information to prepare a reliable assessment.

ISO 10993-1 specifies the special cases and substantiates in which cases characterisation is unnecessary.

What is an accreditation?

An accreditation is the approval of the quality of a company’s work. To obtain accreditation a company must pass an assessment of how it has met several specific and high-quality requirements to quality, employee education, and safety.

Obtaining accreditation is completely optional, although within some trades it is a necessity. That is for instance the case if a company wants to carry out chemical analyses of medical devices. Then the analysis laboratory has to be accredited according to, e.g., ISO 17025 or corresponding standards.

Therefore, an accreditation can be regarded as an official approval of the accredited company. It proves that current standards, current legislation, and regulations are met.

Requirements to an accreditation

The requirements vary according to which standard accreditation will be carried out. An analysis laboratory – such as ours – must be accredited according to ISO/IEC 17025. The standard requires a high level of technical qualifications, and the laboratory must be able to demonstrate accurate and reliable results when carrying out analyses.

Is medicine a medical device?

The name might suggest that medicine is a medical device, but it is not. Instead, medicine or drugs are characterised as pharmaceuticals.

Although medical devices and pharmaceuticals are of vital importance to public health, they differ in many areas. Contrary to medical devices, pharmaceuticals work through absorption and their influence on the biological processes in the body.