What is CE marking and certification?

Imagine that you have developed a revolutionary product, carefully designed with safety, reliability and performance in mind. It is innovative, efficient and ready to go to market. However, an important step must be taken before the product can reach consumers across Europe: CE Marking.

Let's take a quick look at CE Marking and its importance for safety and compliance.

What is CE Marking?

The "CE" symbol is commonly seen on many products in the European Economic Area (EEA), which means that they have been carefully checked to meet strict safety, health, and environmental standards.

CE stands for "Conformité Européenne", French for "European conformity", and is part of EU (European Union) harmonization legislation. CE Marking applies not to all products but is still required to a wide range of products, including construction products, simple pressure vessels, and appliances burning gaseous fuels and is required by EU-based manufacturers or importers of goods into the EU. Its purpose is to ensure that products within its scope are safe and suitable for sale in any EU member state.

CE marking is applied to the product in the final stage. The CE mark must be visible, legible, indelible, and affixed to the device or rating plate. If this is impossible, it must be part of the product packaging and/or accompanying documentation. In general, there is no period of validity for the CE Marking.

Why is CE Marking important?

In the field of medical devices, ensuring their safety and effectiveness is more than critical. CE Marking confirms that a medical device meets the essential standards required for its sale in the EU.

First, CE Marking is a legal requirement for numerous product categories. This isn't just bureaucratic red tape; it's a commitment to protecting consumers and the environment. CE Marking effectively states by the manufacturer (or importer) that the product complies with the EU requirements of the relevant CE Marking directives.

Complying with regulations also opens opportunities for many companies worldwide that want to expand their business. Entry into a new market requires adherence to its rules and regulations, and CE Marking is one of the "golden tickets." Without it, products can face barriers at every border, hindering their reach and stifling their potential.

To put it simply, the benefits of CE Marking bring to the company:

- adhering to legal compliance;

- opportunity to market access;

- ensuring consumer confidence, satisfaction and product liability;

- stand out in global trade as even outside the EEA, CE Marking is often recognized as a symbol of quality and safety.

Which products need CE Marking?

CE Marking is mandatory but only for products covered by the scope of one or more of the New Approach Directives.

CE Marking is mandatory for a wide range of products, including active implantable medical devices, in vitro diagnostic devices, and medical devices, such as diagnostic equipment, surgical instruments, and software used for medical purposes. However, certain exemptions and specific requirements may apply depending on the device's classification and intended use.

Even if a product is manufactured outside the EEA, a company must ensure the product bears CE Marking if its product comes under the scope of a directive requiring CE Marking.

According to the European Commission notes, not all products must have CE Marking. It is forbidden to affix CE Marking to the products beyond the mentioned groups.

How to get CE Marking for medical devices?

There are no strict steps or instructions for getting CE Marking for medical devices. This process can vary depending on the specific characteristics of the medical device and the applicable regulatory requirements. The most relevant standards and regulations for medical devices include the Medical Device Regulation (Regulation (EU) 2017/745), ISO 13485:2016, ISO 14971:2019, and FDA 21 CRF Part 820.

The general steps for CE Marking are outlined below:

• Determine if your product aligns with the definition of a medical device as outlined in the MDR. This includes diagnostic medical devices and other categories.

• Determine the medical device classification in Europe for the medical devices.

• Implement a quality management system (QMS) that complies with the requirements of ISO 13485:2016. The QMS should cover all aspects of the device lifecycle, including design, manufacturing, distribution, and post-market surveillance.

• Prepare a CE Marking Technical File. This file should demonstrate that the device meets the essential requirements set out in the MDR.

• Compile a Clinical Evaluation Report.

• Designate a European Authorized Representative to act on your behalf within the EU if you lack a physical presence in Europe.

• Subject your QMS and Technical File to an audit by a notified body (if applicable). Notified bodies are organizations designated by EU member states to assess the conformity of certain products before being placed on the market.

• Obtain CE certificate for medical devices and ISO 13485 certificates from the designated notified body.

• Make a Declaration of Conformity (DoC) confirming that your device complies with the regulations outlined in the MDR, allowing it to be marketed in the EU single market.

The Matrix team is always happy to answer any questions you might have about ensuring your medical device meets regulatory requirements. Do not hesitate to contact us.