How to Sell Medical Devices in Europe: Step-by-Step Guide
Selling medical devices in Europe requires compliance with the European Union’s medical device regulations before products can be legally placed on the EU market. Manufacturers generally need to determine whether the product falls under the EU Medical Device Regulation (EU MDR 2017/745) or EU In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746), classify the device, complete the required conformity assessment, prepare technical documentation, meet quality and clinical requirements, obtain CE marking where applicable, and complete required registrations.
For manufacturers outside the EU, appointing an EU Authorized Representative is also an important part of market access.
The EU MDR has applied since 26 May 2021, while the IVDR has applied since 26 May 2022.
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What Are the Requirements to Sell Medical Devices in Europe?
To sell a medical device in the European Union, manufacturers should generally:
- Determine whether the product is a medical device or IVD.
- Identify the applicable EU regulation.
- Classify the device according to its risk.
- Establish an appropriate quality management system.
- Prepare technical documentation and evidence of conformity.
- Complete clinical evaluation or performance evaluation, where applicable.
- Work with a Notified Body when required.
- Appoint an EU Authorized Representative if the manufacturer is outside the EU.
- Complete the Declaration of Conformity and apply the CE marking.
- Complete applicable EUDAMED registration and maintain post-market surveillance.
The exact route depends on the device type, classification, intended purpose, and manufacturer location.
Step 1: Determine Whether Your Product Is a Medical Device or IVD
The first step is to establish the regulatory status of your product.
Under the EU MDR, medical devices include products intended for purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or injury, or investigation or modification of anatomy or physiological processes.
Under the EU IVDR, an in vitro diagnostic medical device is generally a product intended to examine specimens derived from the human body to provide information related to physiological or pathological processes, congenital conditions, predisposition, compatibility, or other diagnostic purposes.
This distinction is important because MDR and IVDR have different classification systems and conformity assessment requirements.
Step 2: Identify the Applicable EU Regulation
Medical devices placed on the EU market are primarily regulated under:
- Regulation (EU) 2017/745 – Medical Device Regulation (EU MDR)
- Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (EU IVDR)
The IVDR introduced a risk-based classification system for IVDs and increased the role of independent conformity assessment bodies.
Other EU legislation and standards may also apply depending on the product. For example, electrical or electronic medical devices may need to meet additional requirements related to electrical safety, electromagnetic compatibility, or restricted substances.
Therefore, manufacturers should identify all legislation applicable to their specific device rather than assuming that MDR or IVDR is the only requirement.
Step 3: Classify Your Medical Device
Device classification determines the regulatory pathway and the level of conformity assessment required.
Under the MDR, medical devices are generally classified as:
- Class I
- Class IIa
- Class IIb
- Class III
Classification is based on factors such as intended purpose, duration of use, invasiveness, whether the device is active, and other risk-related characteristics.
IVDs are classified under the IVDR as:
- Class A
- Class B
- Class C
- Class D
The risk level generally increases from Class A to Class D. The European Commission has issued specific guidance for applying IVDR classification rules.
Correct classification is one of the most important steps in European medical device registration because it affects the conformity assessment route, documentation, clinical evidence, and whether a Notified Body is required.
Step 4: Establish a Quality Management System
Manufacturers should establish a quality management system that supports consistent product quality, risk management, documentation, manufacturing controls, and post-market activities.
ISO 13485 is the key international quality management standard commonly used by medical device manufacturers.
Depending on the device and regulatory pathway, a Notified Body may need to assess the manufacturer’s quality management system and other elements of conformity.
Operon Strategist provides ISO 13485 consulting services to help medical device manufacturers establish and maintain compliant quality systems.
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Step 5: Prepare Technical Documentation and Clinical Evidence
Manufacturers must prepare technical documentation demonstrating that the device meets applicable safety and performance requirements.
Depending on the product, documentation may include:
- Device description and specifications
- Intended purpose and indications
- Design and manufacturing information
- Risk management documentation
- Verification and validation records
- Labeling and instructions for use
- Clinical evaluation
- Performance evaluation for IVDs
- Post-market surveillance documentation
Risk management under ISO 14971 and other relevant standards can support the overall compliance process.
The evidence required depends on the device’s classification and regulatory pathway.
Step 6: Complete the Conformity Assessment and CE Marking
For devices requiring third-party assessment, the manufacturer must select an appropriately designated Notified Body.
A Notified Body assesses conformity with the applicable requirements under the MDR or IVDR when third-party involvement is required. The European Commission maintains information on designated Notified Bodies through the NANDO system.
Once the applicable conformity assessment requirements are completed, the manufacturer prepares the EU Declaration of Conformity.
Where required, the CE marking can then be affixed to the device.
Step 7: Appoint an EU Authorized Representative
If the manufacturer is located outside the EU, an EU Authorized Representative is generally required before the device can be placed on the EU market.
The Authorized Representative acts as a regulatory contact between the non-EU manufacturer and EU authorities and has defined responsibilities under the MDR and IVDR.
Importers and distributors also have specific obligations, so manufacturers should clearly define responsibilities across their European supply chain.
Step 8: Register the Manufacturer and Device in EUDAMED
EUDAMED, the European Database on Medical Devices, supports registration and transparency across the medical device lifecycle.
As of 28 May 2026, four EUDAMED modules became mandatory:
- Actor registration
- UDI/Device registration
- Notified Bodies & Certificates
- Market Surveillance
Manufacturers should also ensure that the appropriate European Medical Device Nomenclature (EMDN) codes are used when registering applicable devices. EMDN is used for medical device registration in EUDAMED.
Step 9: Meet Post-Market Surveillance Requirements
European market access does not end after CE marking.
Manufacturers must continue monitoring the safety and performance of their devices through post-market surveillance (PMS) and, where applicable, vigilance activities.
This can include:
- Monitoring complaints and incidents
- Reviewing safety signals
- Reporting serious incidents
- Implementing corrective actions
- Updating risk management documentation
- Conducting required post-market clinical follow-up or other post-market activities
The MDR and IVDR follow a lifecycle-based approach, with stronger emphasis on post-market monitoring and device traceability.
Can a Non-EU Company Sell Medical Devices in Europe?
Yes. A non-EU company can sell medical devices in Europe, but it must meet the applicable EU regulatory requirements. This generally includes conformity assessment, technical documentation, CE marking where applicable, EUDAMED requirements, and appointment of an EU Authorized Representative.
The manufacturer must also consider the roles and obligations of its European importer and distributors.
How Operon Strategist Can Help With EU Medical Device Market Entry
Entering the European medical device market can involve multiple regulatory activities, from classification and technical documentation to QMS implementation, CE marking and post-market compliance.
Operon Strategist supports medical device manufacturers with regulatory and market-entry services, including:
- EU MDR and IVDR regulatory consulting
- CE Marking support
- Medical device classification
- Technical documentation
- ISO 13485 implementation
- Risk management support
- Clinical and performance evaluation support
- EU market entry strategy
- Regulatory documentation and compliance support
Our team can help manufacturers understand the applicable requirements and develop a practical regulatory pathway for entering the European market.
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FAQ's
What are the main requirements to sell medical devices in Europe?
Manufacturers generally need to identify whether the product falls under EU MDR or EU IVDR, classify the device, establish appropriate quality and risk management systems, prepare technical documentation, complete the required conformity assessment, obtain CE marking where applicable, meet EUDAMED requirements, and maintain post-market surveillance.
Can a non-EU manufacturer sell medical devices in Europe?
Yes. A manufacturer located outside the EU can sell medical devices in Europe if the device meets applicable EU regulatory requirements. Non-EU manufacturers generally need to appoint an EU Authorized Representative and comply with requirements for importers and distributors.
What is the difference between EU MDR and EU IVDR?
EU MDR 2017/745 regulates medical devices, while EU IVDR 2017/746 regulates in vitro diagnostic medical devices. The two regulations have different definitions, classification rules, conformity assessment procedures, and evidence requirements.
What are the medical device classes under EU MDR?
Medical devices under EU MDR are generally classified as Class I, Class IIa, Class IIb, or Class III based on factors such as intended purpose, invasiveness, duration of use, and associated risks. Higher-risk devices generally have more extensive conformity assessment requirements.
What are the IVD classes under EU IVDR?
IVDs are classified into Class A, Class B, Class C, and Class D. Classification depends on the intended purpose and risk associated with the IVD. Class D represents the highest-risk category.