Can I sell my medical device in the EU without a CE Mark?

Understanding the legal requirements for marketing medical devices in the EU

The European Union has stringent regulations to ensure the safety, performance, and quality of medical devices. One of the most critical requirements for selling a medical device in the EU is obtaining CE marking. However, are there any circumstances where a medical device can be sold in the EU without a CE mark? Let’s explore the legal framework and possible exceptions.

What is CE Marking and why is it required?

CE marking is a legal requirement under the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. It signifies that a device meets all applicable EU safety, health, and environmental protection requirements before being placed on the EU market.

Manufacturers must undergo a conformity assessment procedure, which may involve a Notified Body, depending on the classification of the device. Once the device is approved, the CE mark is affixed, and the manufacturer can legally sell it across the EU.

When can a medical device be sold without a CE Mark?

In most cases, CE marking is mandatory for all medical devices. However, there are a few exceptions where a medical device can be supplied without a CE mark:

1. Custom-made devices

Custom-made medical devices designed for a specific patient (e.g., 3D-printed prosthetics or dental aligners) do not require CE marking but must still comply with MDR safety and performance requirements. The manufacturer must provide a declaration that the device meets all applicable standards.

2. Investigational devices for clinical studies

Medical devices used exclusively for clinical investigations before market approval do not require a CE mark. However, they must be authorized for use by the competent authority of the EU country where the clinical trial is conducted, and patient safety must be ensured.

3. Humanitarian or compassionate use

Certain EU member states allow unapproved medical devices to be used for compassionate or humanitarian purposes when no alternative treatment is available. This requires authorization from the competent authority and must be strictly controlled to ensure patient safety.

4. Exhibition and demonstration purposes

Manufacturers can display medical devices at trade shows or exhibitions without a CE mark, provided they include a clear disclaimer stating that the device is not yet available for sale in the EU. These devices cannot be used on patients until they achieve CE certification.

5. Special national exemptions

Some EU countries may grant temporary exemptions for specific medical devices during emergencies (such as a pandemic) or when a public health need justifies the use of a non-CE-marked device. These exemptions are granted on a case-by-case basis by national authorities.

Consequences of selling a medical device without CE Marking

Attempting to sell a medical device in the EU without a CE mark in violation of MDR requirements can lead to serious consequences:

• Product recalls and removal from the market
• Fines and legal penalties
• Reputational damage and loss of business opportunities
• Liability for harm caused to patients

Enforcement is carried out by EU national competent authorities, and non-compliant devices can be seized or restricted from entering the market.

How to obtain CE Marking for your dedical device

If your medical device requires CE marking, you must:

• Determine the classification of your device (Class I, IIa, IIb, or III under MDR).
• Conduct a conformity assessment – Self-certification for low-risk devices, Notified Body approval for higher-risk devices.
• Prepare technical documentation – Including risk analysis, clinical evaluation, and labeling compliance.
• Implement a Quality Management System (QMS) – Compliance with ISO 13485 is highly recommended.
• Register your device and manufacturer information in EUDAMED, the EU database for medical devices.

Once you complete these steps and your device is certified, you can affix the CE mark and legally place the product on the EU market.

Conclusion: CE Marking is Essential for Most Medical Devices

Selling a medical device in the EU without a CE mark is generally illegal, except in very limited circumstances such as custom-made devices, clinical investigations, or specific national exemptions. Manufacturers should ensure full compliance with MDR/IVDR to avoid legal risks and facilitate smooth market entry.

If you are planning to introduce a medical device in the EU market, obtaining CE certification should be your top priority to ensure regulatory approval, market acceptance, and patient safety.