CE marking is about safety – both for you as the developer and for those who will use the product. Here are three typical product categories we often help with.

Electronic products often have to meet the requirements of three key directives:

• Low Voltage Directive (LVD) – requirements for electrical safety during normal use.
• EMC Directive – requirements that the product does not interfere with or is interfered with by other electronics.
• RoHS Directive – environmental requirements for the content of harmful substances.

To meet the requirements, you must document the product's properties, perform relevant tests and create technical documentation – often based on harmonized standards.

At Inventas, we build electronic solutions from idea to finished product. We work with everything from IoT and sensors to FPGAs and ASICs, and have a strong professional environment within testing, control and regulation. This means that we also know the requirements – and how to best meet them.

We help you with:

• choosing which standards and tests apply
• development of printed circuit boards and embedded systems
• test strategy and documentation flow
• assessment of manufacturability and conformity

If you develop software that is to be used for medical purposes (e.g. diagnostics, health monitoring or treatment), then this is considered a medical device, and then there is a requirement for CE marking. Then you must follow the Medical Device Regulation (MDR) in order to CE mark the software. When the software includes artificial intelligence, the process becomes more complex.

You must document:

• what the software does, how it is built and what data it uses
• how the algorithms work and are validated
• that data security, privacy and traceability are ensured

For AI-based products, new requirements will be introduced through the AI ​​Act, which introduces risk categories and stricter requirements for transparency, monitoring and testing. At Inventas, we follow developments closely and help you set up your documentation so that it meets both current and future requirements.

If you are developing medical devices, you must comply with both the CE marking requirements and the MDR – Medical Device Regulation. The MDR is a regulation that applies throughout the EU/EEA and sets its own strict requirements for medical devices. It regulates how the product should be developed, documented and followed up – and is therefore a central part of the CE marking for this type of product. The MDR places higher demands on traceability, safety and documentation, and involves a much more comprehensive assessment of the product's risk, function and performance.

Among other things, you must – depending on the product's properties and area of ​​application:

• classify the product in the correct risk class (I to III), depending on how much risk the product may pose and how it will be used
• establish and follow a quality system in line with ISO 13485 (a standard for safe and structured development of medical devices)
• prepare a technical file with specifications, clinical evaluation, risk assessment and test documentation
• involve a technical inspection body for assessment (applies to all classes except low risk)

Inventas has been ISO 13485 certified since 2022. This means that we have the systems, procedures and experience needed to support you every step of the way. You get a development partner who knows both the requirements and what it actually takes to meet them – in practice. We also help you find out if your product is actually a medical device – for the many grey area products.