For medical device manufacturers planning to enter the European market, CE marking is one of the most important regulatory requirements to understand. In most cases, a medical device must meet applicable European Union requirements and carry the CE mark before it can be legally placed on the EU market.
However, there are limited exceptions and specific regulatory circumstances in which a device may be supplied without CE marking. Understanding these conditions helps manufacturers avoid compliance problems, shipment delays, and restrictions on commercial distribution.
This guide explains when CE marking is required, which exceptions may apply, and what manufacturers should consider before launching a device in Europe.
1. Is Selling Medical Devices in Europe Without CE Marking Possible?
Selling medical devices in Europe without CE marking is not possible for devices intended for ordinary commercial distribution unless a specific legal exception or authorization applies.
Under the EU Medical Device Regulation (EU MDR 2017/745), manufacturers must demonstrate that their devices meet the applicable safety and performance requirements. The required conformity assessment must be completed before the device is placed on the market.
CE marking indicates that the manufacturer declares conformity with the applicable EU legislation. Depending on the device classification, the conformity assessment may require involvement from a designated notified body.
A device manufactured outside the EU is not exempt simply because it has already been marketed in another country. FDA clearance or approval, for example, does not automatically establish compliance with EU MDR requirements.
Manufacturers should therefore confirm the device’s regulatory status before supplying it to European distributors, hospitals, clinics, or other customers.
2. Understanding CE Marking for Medical Devices
CE marking for medical devices is the conformity marking used for devices that meet the applicable European regulatory requirements.
Before affixing the mark, the manufacturer must complete the appropriate conformity assessment process. Depending on the device, this may involve:
- Establishing the device’s intended purpose and classification.
- Preparing technical documentation.
- Demonstrating compliance with applicable General Safety and Performance Requirements.
- Completing clinical evaluation and providing supporting evidence.
- Implementing an appropriate quality management system.
- Completing notified-body assessment when required.
- Preparing the EU Declaration of Conformity and addressing applicable registration obligations.
Class I devices that are non-sterile, have no measuring function, and are not reusable surgical instruments can generally follow a manufacturer-led conformity assessment route. Other Class I devices and higher-risk devices may require notified-body involvement. The exact process depends on the product type, classification, and applicable provisions of the EU MDR. Manufacturers should not assume that every device follows the same route.
3. EU MDR CE Marking Requirements
The EU MDR CE marking requirements are primarily established under Regulation (EU) 2017/745.
The regulation sets requirements covering device safety, performance, clinical evidence, technical documentation, conformity assessment, and post-market responsibilities.
Before placing a device on the market, manufacturers should establish which requirements apply to their product and identify the appropriate conformity assessment procedure.
For devices requiring a notified body, the manufacturer must obtain the necessary assessment and certification before completing the applicable CE-marking process. Where notified-body involvement is not required, the manufacturer must still meet the relevant legal requirements and maintain the required documentation.
CE marking is not a general certificate that can be transferred from one product to another. It applies to the specific device and relevant regulatory framework.
Official reference: EU Medical Device Regulation 2017/745.
4. Exceptions to CE Marking Under EU MDR
There are specific circumstances in which devices may be supplied or used without the standard CE-marking route. The exceptions to CE marking under EU MDR are limited and subject to defined conditions.
Custom-made medical devices
Certain custom-made devices can be made available without CE marking when the applicable requirements are met. Under the EU MDR, manufacturers must follow the relevant custom-made device provisions, including the requirements in Article 21 and Annex XIII.
Under EU MDR 2017/745, custom-made devices (CMDs) are exempt from the standard CE marking requirement, provided they strictly comply with the specific legal and technical obligations set out in the regulation.
A device is not automatically considered custom-made simply because it is produced in a small quantity or customized for a customer. Its legal status depends on the regulatory definition and applicable conditions.Investigational devices
Investigational devices used exclusively for clinical investigations may be supplied without CE marking, provided the requirements of Articles 62-80, Article 82, and Annex XV of the MDR are met. These devices are not considered commercially marketed products.
Exhibition and Demonstration Devices
Devices may be displayed at trade fairs, exhibitions, demonstrations, or similar events before CE marking, provided a visible notice indicates that the device is not yet compliant with EU MDR requirements and cannot be placed on the market until conformity has been achieved.
National derogations
Under Article 59 of the EU MDR, a competent authority may authorize the placing on the market or putting into service of a specific device without the usual conformity assessment in duly justified circumstances involving public health or patient safety or health.
This is an exceptional, authority-controlled route. Manufacturers cannot rely on it without the relevant authorization.
Transitional provisions
Certain eligible devices previously certified under the older Medical Devices Directives may continue to be placed on the market under transitional provisions if all applicable conditions are met.
These arrangements do not create a general exemption from CE marking. Eligible legacy devices generally rely on existing conformity documentation and must satisfy the relevant transitional requirements.
Manufacturers should review the current regulation and official guidance before deciding that an exception applies.
Eligibility for MDR transitional provisions depends on compliance with the conditions specified in MDR Article 120 and subsequent amendments. Manufacturers should verify that their devices remain eligible before relying on transitional arrangements.
5. What Does Placing a Medical Device on the EU Market Mean?
Placing a medical device on the EU market means making a device available for the first time on the EU market, other than a device intended for investigation, in the course of a commercial activity, whether for payment or free of charge.
This distinction matters because different regulatory provisions apply to commercial distribution, clinical investigations, and certain special-purpose devices.
A manufacturer should not assume that supplying a device free of charge removes regulatory obligations. A donated device intended for ordinary clinical use may still need to comply with the applicable market-placement requirements.
Before distribution, companies should confirm the intended purpose, regulatory classification, conformity status, labeling, and applicable economic-operator obligations.
6. Conformity Assessment for Medical Devices
Conformity assessment for medical devices is the process used to demonstrate that a device satisfies the applicable EU MDR requirements.
The procedure depends on the device’s risk classification and other relevant characteristics. Some devices can undergo manufacturer-led assessment, while others require a notified body to evaluate specified aspects of conformity.
Manufacturers should plan for the evidence and documentation needed to support the selected route. Depending on the product, this can include risk management, clinical evaluation, performance testing, technical documentation, quality management, and post-market surveillance arrangements.
Completing conformity assessment early in the development process can help identify documentation gaps before a planned European launch.
7. How Manufacturers Can Prepare for European Market Entry
Before launching a medical device in Europe, manufacturers should:
- Confirm whether the product falls under the EU MDR or another regulatory framework, such as the In Vitro Diagnostic Regulation.
- Determine the correct device classification.
- Identify the applicable conformity assessment route.
- Prepare the required technical and clinical documentation.
- Determine whether a notified body is needed.
- Review labeling, registration, and economic-operator requirements.
- Verify whether any claimed exception or transitional provision applies.
- Maintain procedures for post-market surveillance, complaints, and corrective actions.
For manufacturers based outside the EU, additional obligations, including appointing an EU authorized representative where required, should also be addressed.
Conclusion
Most medical devices intended for ordinary commercial distribution in the European Union must meet applicable regulatory requirements and carry CE marking before being placed on the market.
Limited exceptions exist for circumstances such as qualifying custom-made devices, investigational devices, and specific authorizations granted under the EU MDR. Transitional provisions may also apply to certain eligible legacy devices, but these provisions have defined conditions.
Manufacturers should verify the regulatory status of each product rather than assuming that a device can be sold without CE marking because it is already marketed elsewhere.
For support with medical device regulatory strategy, conformity assessment, and European market entry, visit CliniExperts International.
