Updated: 24th July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Are Medical Device Distributor Responsibilities Under the EU MDR?
Medical device distributors play a critical role in ensuring that only compliant medical devices are made available on the European Union market. While distributors are not responsible for designing or manufacturing medical devices, Regulation (EU) 2017/745 (EU MDR) places specific legal obligations on them to verify compliance before supplying products and to support ongoing post-market surveillance activities.
Under Article 14 of the EU MDR, distributors act as an important safeguard within the medical device supply chain. They must exercise due care when making devices available, verify that key regulatory requirements have been met and take appropriate action if they believe a product does not comply with the legislation.
Unlike manufacturers, distributors are generally not responsible for preparing Technical Documentation, conducting Clinical Evaluations or affixing the CE marking. However, they must ensure that the products they supply have already met these requirements before they are placed on the market. This includes verifying that devices bear the CE marking where required, are accompanied by the necessary information and instructions, and have been supplied by manufacturers and importers that have fulfilled their own regulatory obligations.
Distributors also have continuing responsibilities after a device has entered the market. They must maintain appropriate storage and transport conditions, cooperate with manufacturers, Authorised Representatives, importers and competent authorities, retain records where required and report complaints or suspected non-compliance through the appropriate channels. These activities help preserve product safety, maintain traceability and support the effectiveness of the EU MDR’s post-market surveillance framework.
Although Article 14 sets out the specific obligations of distributors, compliance is a shared responsibility across the entire medical device supply chain. Manufacturers, Authorised Representatives, importers and distributors each perform different but complementary roles to ensure that medical devices remain safe, effective and compliant throughout their lifecycle.
Understanding these responsibilities is essential for any organisation that distributes medical devices within the European Union, regardless of whether they supply hospitals, healthcare professionals or other distributors.
New to the EU MDR?
This article focuses on the legal responsibilities of medical device distributors under Article 14 of Regulation (EU) 2017/745. For a complete introduction to the EU MDR, including manufacturer obligations, device classification, GSPRs, clinical evaluation, technical documentation, UDI, EUDAMED and CE marking requirements, explore our EU MDR for Beginners Guide.
MDR Article 14: Legal Responsibilities of Distributors
Article 14 of Regulation (EU) 2017/745 establishes the legal obligations that apply to medical device distributors operating within the European Union. A distributor is defined as any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a medical device available on the market up until the point it is put into service.
The purpose of Article 14 is to ensure that distributors actively contribute to maintaining the safety, performance and regulatory compliance of medical devices. Rather than acting as passive suppliers, distributors are expected to exercise due care when handling medical devices and verify that the products they supply meet the applicable requirements of the EU MDR.
Before making a device available on the market, distributors must verify, where applicable, that:
- The device bears a valid CE marking.
- An EU Declaration of Conformity has been drawn up by the manufacturer.
- The device is accompanied by the required Instructions for Use and labelling in the appropriate language(s).
- A UDI has been assigned where required by the Regulation.
- Imported devices identify both the importer and, where applicable, the Authorised Representative.
If a distributor believes that a device does not comply with the EU MDR, they must not make the product available until the non-conformity has been corrected. Where there is reason to believe that a device presents a serious risk or is falsified, the distributor must immediately inform the manufacturer or Authorised Representative, the importer where applicable, and the relevant competent authorities.
Distributors are also responsible for ensuring that storage and transport conditions do not compromise the conformity of the device while it remains under their control. This obligation extends throughout warehousing, transportation and distribution activities and forms an important part of maintaining product safety after CE marking has been achieved.
Article 14 further requires distributors to cooperate with manufacturers and competent authorities by providing documentation, supporting investigations, participating in corrective actions and maintaining traceability records where required. These obligations continue throughout the period that the distributor makes the device available on the market and remain an important element of the EU MDR’s post-market surveillance system.
Although Article 14 specifically addresses distributors, it works alongside Articles 10, 11 and 13, which establish the responsibilities of manufacturers, Authorised Representatives and importers. Together, these provisions create a coordinated regulatory framework in which every economic operator has clearly defined responsibilities for maintaining compliance throughout the medical device supply chain.
Need Help Achieving CE Marking?
This article explains the responsibilities of medical device distributors once a device has been CE marked. If you're looking for a complete guide to obtaining CE marking under the EU MDR, including classification, conformity assessment, Technical Documentation, Clinical Evaluation and Notified Body requirements, read our CE Marking Medical Devices Guide.
Understanding Manufacturer Responsibilities Under the EU MDR
While Article 14 defines the legal responsibilities of medical device distributors, Article 10 establishes the overarching obligations placed on manufacturers throughout the device lifecycle. Learn how manufacturers manage quality management systems, Technical Documentation, risk management, clinical evaluation, post-market surveillance and regulatory compliance in our Article 10 EU MDR Guide.
What Must Distributors Verify Before Making a Device Available?
Before supplying a medical device within the European Union, distributors must carry out a series of verification checks to ensure that the device complies with the applicable requirements of the EU MDR. These checks are intended to identify obvious regulatory deficiencies before products reach healthcare providers or patients and form one of the distributor’s primary legal responsibilities under Article 14.
Importantly, distributors are not expected to perform a detailed technical assessment of the device or review the manufacturer’s Technical Documentation. Instead, they must verify that the information and documentation required by the Regulation are present and appear to be complete and compliant.
Verify the CE Marking
Distributors should confirm that the device bears the appropriate CE marking before making it available on the market. The CE marking demonstrates that the manufacturer has declared conformity with the applicable legislation and, where required, successfully completed the relevant conformity assessment procedure.
For devices requiring Notified Body involvement, distributors should also verify that the identification number of the Notified Body accompanies the CE marking where applicable.
Check the Labelling and Instructions for Use
The device should be supplied with compliant labelling and, where required, Instructions for Use that meet the language requirements of the Member State in which the device is being supplied.
Distributors should verify that the labelling appears complete and includes information such as:
- Manufacturer details.
- Device identification.
- UDI carrier where applicable.
- Lot number or serial number.
- Expiry date where relevant.
- Sterility information where applicable.
- Appropriate safety information and warnings.
Missing or incomplete labelling may indicate that the device should not be supplied until the issue has been resolved.
Need to Understand Medical Device Labelling Requirements?
One of a distributor's key responsibilities under Article 14 of the EU MDR is verifying that medical devices are supplied with compliant labelling and, where required, the appropriate Instructions for Use. Learn what information must appear on medical device labels, how labelling supports regulatory compliance and the requirements under the EU MDR, UK MDR and FDA regulations in our Medical Device Labelling Guide.
Confirm the Manufacturer and Importer Information
Where applicable, distributors should verify that the manufacturer’s details are clearly identified on the device and that imported products also identify the EU importer in accordance with Article 13 of the MDR.
If the manufacturer is established outside the European Union, the details of the EU Authorised Representative should also be present where required.
Verify the Device Has Not Been Compromised
Distributors should inspect products for any obvious signs that may affect compliance or patient safety, including:
- Damaged or opened packaging.
- Broken sterility barriers.
- Missing labels.
- Incorrect storage conditions.
- Expired products.
- Evidence of tampering or counterfeiting.
Where any concerns exist, the device should not be supplied until the issue has been investigated and resolved.
Maintain Due Care
The EU MDR requires distributors to exercise an appropriate level of due care throughout their activities. This means remaining alert to potential compliance issues rather than assuming that every device received from a manufacturer or importer is automatically suitable for supply.
Where a distributor has reason to believe that a device is not compliant with the Regulation, they must refrain from making the device available until the non-conformity has been corrected. If the device presents a serious risk or is suspected to be falsified, the distributor must promptly inform the manufacturer or Authorised Representative, the importer where applicable, and the relevant competent authorities.
By performing these straightforward but essential verification checks, distributors help prevent non-compliant devices from entering the healthcare system while supporting the overall objectives of the EU MDR to protect patients and maintain confidence in medical devices.
The following checklist summarises the key verification activities that distributors should complete before making a medical device available on the EU market. While the extent of these checks will depend on the nature of the device and the distributor’s role within the supply chain, carrying out these basic verifications helps demonstrate due care and supports compliance with Article 14 of the EU MDR.
| Verification | Required? | Why It Matters |
|---|---|---|
| CE marking present | ✓ | Demonstrates conformity assessment has been completed where applicable. |
| Labelling complete | ✓ | Ensures users receive the information required for safe use. |
| Instructions for Use included (where required) | ✓ | Supports safe and effective operation of the device. |
| Manufacturer identified | ✓ | Enables traceability and regulatory accountability. |
| Importer details present (where applicable) | ✓ | Confirms compliance with Article 13 requirements. |
| EU Authorised Representative identified (where applicable) | ✓ | Required for manufacturers established outside the EU. |
| UDI carrier present (where applicable) | ✓ | Supports traceability throughout the supply chain. |
| Packaging intact | ✓ | Helps maintain product integrity and sterility where applicable. |
| Storage conditions maintained | ✓ | Prevents damage that could affect conformity or performance. |
These verification activities represent only one aspect of a distributor’s responsibilities. Once a device has been placed under the distributor’s control, they must also ensure that appropriate storage, transport and traceability measures are maintained to preserve the device’s conformity and performance.
Storage, Transport and Traceability Requirements
A distributor’s responsibilities do not end once they have verified that a medical device complies with the requirements of the EU MDR. While a device remains under the distributor’s control, appropriate storage, handling and transport conditions must be maintained to ensure that its conformity, safety and performance are not compromised.
Article 14 requires distributors to comply with any conditions specified by the manufacturer during storage and transportation. These requirements may include temperature and humidity limits, protection from excessive light or moisture, handling precautions for sterile devices and controls designed to prevent physical damage during transit. Failure to maintain these conditions could affect the performance of the device and potentially invalidate its conformity with the Regulation.
Maintaining Appropriate Storage Conditions
Medical devices should be stored in accordance with the manufacturer’s documented requirements. Depending on the type of device, distributors may need to monitor environmental conditions, implement stock rotation procedures and ensure that products remain within their stated shelf life before distribution.
Distributors should also routinely inspect inventory for:
- Damaged packaging.
- Broken sterility barriers.
- Expired products.
- Incorrect storage conditions.
- Signs of contamination or deterioration.
- Products subject to safety notices or recalls.
Where any concerns are identified, affected devices should be isolated until the manufacturer or importer has confirmed the appropriate course of action.
Safe Transport of Medical Devices
Transportation arrangements should ensure that devices continue to meet the manufacturer’s specified conditions throughout delivery. Packaging should adequately protect the product from damage, contamination and environmental conditions that could affect safety or performance.
For devices requiring controlled environmental conditions, distributors should ensure that suitable transport systems are used and that any monitoring records are retained where appropriate.
Maintaining Traceability
Effective traceability enables medical devices to be identified, located and, where necessary, withdrawn from the market quickly. Although manufacturers are primarily responsible for implementing the Unique Device Identification (UDI) system, distributors also contribute by maintaining accurate records of the products they receive and supply.
Good traceability practices may include recording:
- Product name and catalogue number.
- UDI where applicable.
- Lot number or serial number.
- Quantity received and supplied.
- Date of receipt and dispatch.
- Supplier and customer details.
Maintaining accurate distribution records supports post-market surveillance activities, facilitates Field Safety Corrective Actions (FSCAs) and allows affected devices to be identified rapidly if a recall or safety notice is issued.
Confused About UDI Requirements?
Distributors play an important role in verifying that medical devices carry the correct Unique Device Identification (UDI) and in maintaining traceability throughout the supply chain. Learn how UDI works, what the UDI-DI and UDI-PI mean, and how UDI supports compliance under the EU MDR in our Medical Device UDI for Beginners Guide.
Supporting Market Surveillance
Distributors should have procedures that enable them to respond promptly to requests from manufacturers or competent authorities for information relating to specific devices. Accurate records and effective traceability systems help ensure that corrective actions can be implemented efficiently and minimise the potential impact on patients and healthcare providers.
By maintaining appropriate storage conditions, protecting devices during transport and preserving accurate traceability records, distributors play an essential role in maintaining regulatory compliance and ensuring that medical devices remain safe and effective throughout the supply chain.
The table below summarises some of the practical controls that distributors should implement to maintain device conformity while products are stored, transported and supplied throughout the distribution chain.
| Activity | Why It Is Important |
|---|---|
| Store devices according to the manufacturer’s instructions | Preserves safety, performance and conformity. |
| Monitor environmental conditions where required | Prevents deterioration caused by unsuitable temperatures or humidity. |
| Inspect stock regularly | Identifies damaged, expired or non-compliant devices before supply. |
| Rotate stock appropriately | Reduces the risk of supplying expired products. |
| Maintain distribution records | Supports traceability and post-market surveillance. |
| Record UDI, lot or serial numbers where appropriate | Enables rapid identification during recalls or investigations. |
| Retain supplier and customer information | Facilitates Field Safety Corrective Actions and competent authority requests. |
| Protect products during transport | Prevents damage that could affect device conformity. |
Learn More About Post-Market Surveillance
Distributors play an important role in supporting post-market surveillance by reporting complaints, identifying potential safety issues and cooperating with manufacturers during investigations and corrective actions. To understand how manufacturers establish Post-Market Surveillance (PMS) systems, develop PMS Plans, manage vigilance activities and maintain ongoing compliance under the EU MDR, read our Post-Market Surveillance for Medical Devices Guide.
Complaint Handling, Vigilance and Corrective Actions
Medical device distributors play an important role in the EU MDR post-market surveillance system by helping manufacturers identify and respond to safety and performance issues that arise after a device has been placed on the market. Although distributors are not generally responsible for investigating incidents or submitting vigilance reports, they have clear legal obligations to cooperate with manufacturers and competent authorities when concerns are identified.
Distributors should have documented procedures for receiving, recording and communicating complaints relating to medical devices they have supplied. Complaints may originate from healthcare professionals, patients, procurement teams or other distributors and should be reviewed promptly to determine whether they indicate a potential regulatory or safety issue.
Reporting Complaints to the Manufacturer
Where a complaint relates to the safety, quality or performance of a medical device, distributors should notify the manufacturer without undue delay. Timely communication enables the manufacturer to investigate the issue, determine whether corrective action is required and fulfil their own obligations under the EU MDR.
Examples of issues that should be reported include:
- Device malfunctions.
- Packaging defects.
- Labelling errors.
- Incorrect or missing Instructions for Use.
- Suspected performance failures.
- Customer complaints suggesting a potential safety risk.
Maintaining clear communication between distributors and manufacturers helps ensure that emerging trends are identified early and addressed before they affect a larger number of patients.
Supporting Vigilance Activities
Where a distributor believes that a device presents a serious risk or has been falsified, Article 14 requires them to immediately inform the manufacturer or Authorised Representative, the importer where applicable, and the relevant competent authorities.
Distributors should also cooperate with manufacturers during incident investigations by providing information such as:
- Distribution records.
- Batch or serial numbers.
- Customer information where appropriate.
- Details of returned products.
- Copies of complaints received.
This information supports effective root cause investigations and enables manufacturers to fulfil their vigilance reporting obligations.
Field Safety Corrective Actions and Recalls
When a manufacturer initiates a Field Safety Corrective Action (FSCA) or product recall, distributors play a key role in ensuring that affected devices are identified quickly and removed from the supply chain where necessary.
Typical distributor responsibilities during an FSCA include:
- Identifying affected stock using traceability records.
- Ceasing further distribution of affected devices.
- Informing customers where instructed by the manufacturer.
- Returning or quarantining affected products.
- Maintaining records of actions taken.
Having accurate distribution records significantly improves the speed and effectiveness of corrective actions and helps minimise risks to patients and healthcare providers.
Cooperation with Competent Authorities
Competent authorities may request information from distributors during inspections, market surveillance activities or investigations into non-compliant devices. Distributors are required to cooperate with these requests by providing relevant documentation and any information necessary to demonstrate compliance with the Regulation.
Establishing documented complaint handling procedures, maintaining effective communication with manufacturers and responding promptly to safety concerns are all essential elements of a compliant quality system. Together, these activities support the broader objectives of the EU MDR by helping to identify risks early, facilitate corrective actions and ensure that only safe and compliant medical devices remain available on the European market.
Common Compliance Mistakes Made by Medical Device Distributors
Despite the responsibilities of distributors being clearly defined within Article 14 of the EU MDR, non-compliance is still commonly identified during regulatory inspections and market surveillance activities. Many issues arise not because distributors deliberately disregard the Regulation, but because they misunderstand the extent of their legal obligations or assume that compliance rests solely with the manufacturer.
Understanding these common mistakes can help distributors strengthen their compliance procedures, reduce regulatory risk and contribute to maintaining the safety and performance of medical devices throughout the supply chain.
Assuming the Manufacturer Is Solely Responsible
One of the most common misconceptions is that distributors have no regulatory responsibilities because they do not manufacture the device. While manufacturers remain responsible for demonstrating conformity with the EU MDR, distributors have independent legal obligations that must be fulfilled before and after making a device available on the market.
Failure to carry out the verification activities required by Article 14 may itself constitute non-compliance, regardless of whether the manufacturer’s documentation is complete.
Failing to Verify Devices Before Supply
Distributors should always perform the required verification checks before supplying a device. Placing products on the market without confirming the presence of the CE marking, compliant labelling, Instructions for Use where required and the relevant economic operator information increases the risk of supplying non-compliant devices.
Implementing a documented incoming inspection process can significantly reduce this risk.
Poor Storage and Transport Controls
Medical devices can lose conformity if they are stored or transported outside the conditions specified by the manufacturer. Inadequate environmental controls, damaged packaging or poor stock management may compromise product safety and performance even where the device was fully compliant when received.
Maintaining documented procedures for storage, handling and transportation helps ensure that devices remain compliant while under the distributor’s control.
Inadequate Traceability Records
Without accurate distribution records, identifying affected products during a recall or Field Safety Corrective Action can become extremely difficult. Poor traceability may delay corrective actions, increase patient risk and make it harder to demonstrate compliance during inspections.
Distributors should ensure that appropriate records are maintained for the products they receive and supply, including relevant identification and distribution information.
Delaying the Reporting of Complaints
Complaints relating to device safety or performance should never be ignored or left unresolved. Delays in communicating concerns to the manufacturer may prevent timely investigations and increase the likelihood of further incidents occurring.
Clear internal procedures for recording, escalating and communicating complaints help ensure that potential safety issues are addressed promptly.
Lack of Documented Procedures
Many distributors operate effective processes in practice but fail to document them. During regulatory inspections, organisations may be asked to demonstrate how they verify incoming devices, manage complaints, maintain traceability and control storage conditions.
Documented procedures not only support regulatory compliance but also help ensure that responsibilities are applied consistently across the organisation.
By understanding these common compliance pitfalls and implementing robust quality processes, distributors can meet their obligations under the EU MDR while supporting manufacturers, healthcare providers and competent authorities in maintaining the safety and effectiveness of medical devices throughout their lifecycle.
Worked Example: Responding to a Non-Compliant Medical Device
Understanding the legal responsibilities of distributors is often easier when applied to a real-world scenario. The following example demonstrates how a distributor should respond when a potential non-compliance is identified before a medical device is supplied to customers.
Scenario
A distributor receives a shipment of CE-marked infusion pumps from an importer for supply to hospitals within the European Union. During the incoming goods inspection, warehouse staff identify that the devices bear the CE marking, but the packaging does not include the importer’s details as required under the EU MDR. In addition, several cartons contain Instructions for Use in the wrong language for the Member State where the devices are intended to be supplied.
Correct Response
Rather than distributing the products, the distributor immediately places the affected stock into quarantine and suspends further supply. The importer is contacted and informed of the identified non-conformities, while the manufacturer is notified so that corrective actions can be implemented.
The distributor documents the issue within its quality management procedures, records the affected batch numbers and retains all correspondence relating to the investigation. The devices are only released for sale once compliant labelling and the correct Instructions for Use have been provided, and the distributor is satisfied that the requirements of Article 14 have been met.
Why This Matters
By identifying the non-conformities before the devices were made available on the market, the distributor fulfilled its obligation to exercise due care under the EU MDR. Preventing non-compliant products from reaching healthcare providers protects patient safety, supports the manufacturer’s regulatory compliance and reduces the risk of enforcement action by competent authorities.
This example demonstrates that distributors are not expected to reassess the technical design or clinical performance of medical devices. Instead, their role is to verify that the products they receive appear to comply with the applicable regulatory requirements and to take appropriate action whenever concerns are identified. By implementing robust verification procedures and maintaining effective communication with manufacturers, importers and Authorised Representatives, distributors become an essential part of the EU MDR compliance framework.
Conclusion
Medical device distributors are an essential part of the regulatory framework established by the EU MDR. Although they are not responsible for designing or manufacturing medical devices, they have independent legal obligations to ensure that only compliant devices are made available on the European market.
By verifying CE marking and regulatory information before supply, maintaining appropriate storage and transport conditions, preserving traceability records and cooperating with manufacturers and competent authorities, distributors help protect patient safety and support the continued compliance of medical devices throughout their lifecycle.
Organisations that distribute medical devices should ensure that these responsibilities are supported by documented procedures, appropriate staff training and effective quality management processes. Taking a proactive approach to compliance not only reduces regulatory risk but also helps maintain confidence in the safety and performance of the products supplied to healthcare professionals and patients.
Understanding and implementing the requirements of Article 14 is therefore an important part of operating successfully within the European medical device supply chain.
Need Support Understanding Your Responsibilities Under the EU MDR?
Whether you are a manufacturer, importer or medical device distributor, understanding your responsibilities under the EU MDR is essential for maintaining compliance and protecting patient safety. Patient Guard provides expert regulatory consultancy to help organisations interpret the requirements of Regulation (EU) 2017/745, implement compliant quality management systems and develop practical procedures that support ongoing regulatory compliance.
Our experienced consultants can assist with MDR compliance, ISO 13485 quality management systems, Technical Documentation, Post-Market Surveillance (PMS), regulatory gap assessments and wider quality and regulatory support for medical device organisations operating throughout the UK and European Union.
Frequently Asked Questions About CE Marking and Distributor Responsibilities
A medical device distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a medical device available on the European Union market before it is put into service. Distributors have specific legal responsibilities under Article 14 of Regulation (EU) 2017/745 (EU MDR).
Distributors must exercise due care when making medical devices available on the market. Their responsibilities include verifying CE marking, checking labelling and Instructions for Use, maintaining appropriate storage and transport conditions, preserving traceability, reporting complaints and cooperating with manufacturers and competent authorities.
Distributor responsibilities are set out in Article 14 of Regulation (EU) 2017/745. This article explains the verification activities distributors must perform before supplying medical devices and the ongoing obligations they have while products remain under their control.
No. Distributors are not responsible for obtaining CE marking or preparing the Technical Documentation. These responsibilities remain with the manufacturer. However, distributors must verify that devices bear the appropriate CE marking and appear to comply with the applicable requirements before making them available on the market.
If a distributor believes that a medical device does not comply with the EU MDR, they must not make the device available until the non-conformity has been resolved. Where a device presents a serious risk or is suspected to be falsified, the distributor must promptly inform the manufacturer or Authorised Representative, the importer where applicable, and the relevant competent authorities.
Distributors should maintain appropriate records to support traceability, including product identification, lot or serial numbers where applicable, supplier information and distribution records. These records assist with post-market surveillance activities, investigations and Field Safety Corrective Actions (FSCAs).
Manufacturers are responsible for initiating recalls and Field Safety Corrective Actions. However, distributors play an important supporting role by identifying affected stock, suspending further distribution, informing customers where instructed and maintaining records of the actions taken.
The EU MDR does not specifically require distributors to be certified to ISO 13485. However, many distributors implement quality management procedures based on ISO 13485 principles to help demonstrate compliance, improve traceability and manage complaints, storage and distribution activities effectively.
Failure to comply with Article 14 may result in enforcement action by the relevant competent authority. Non-compliance can also increase the risk of supplying unsafe or non-compliant medical devices, potentially leading to recalls, reputational damage and legal consequences.
Importers are responsible for placing devices from manufacturers outside the European Union onto the EU market for the first time and have obligations under Article 13 of the EU MDR. Distributors make devices available further along the supply chain and have separate responsibilities under Article 14, including verification checks, storage, transport and traceability.
Yes. While manufacturers are responsible for operating the Post-Market Surveillance (PMS) system, distributors contribute by recording complaints, communicating safety concerns, supporting investigations and cooperating during vigilance activities and Field Safety Corrective Actions.
Patient Guard provides expert regulatory consultancy to organisations throughout the medical device supply chain. Our consultants can help distributors understand their obligations under the EU MDR, develop compliant procedures, implement quality management systems, perform regulatory gap assessments and support ongoing compliance with Regulation (EU) 2017/745.
References
This guide is based on the following legislation and official regulatory guidance relating to CE marking and the responsibilities of economic operators under Regulation (EU) 2017/745 (MDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Defines the legal responsibilities of manufacturers, Authorised Representatives, importers and distributors, including the obligations set out in Articles 13 and 14 relating to CE-marked medical devices. |
| European Commission | Authorised Representatives, Importers and Distributors | Provides official European Commission guidance explaining the legal roles, responsibilities and obligations of economic operators throughout the medical device supply chain. |
| European Commission | Economic Operators | Explains the responsibilities of manufacturers, Authorised Representatives, importers and distributors, supporting the shared compliance responsibilities described throughout this guide. |
| European Commission | Notified Bodies for Medical Devices | Provides official information on the conformity assessment process that leads to CE certification for higher-risk medical devices before they enter the European supply chain. |
| European Commission | EU Declaration of Conformity (DoC) | Explains the purpose and regulatory requirements of the EU Declaration of Conformity, which distributors and importers should verify as part of their compliance responsibilities. |
Supply chain responsibilities continue to evolve through legislation and regulatory guidance. Manufacturers, importers, distributors and other economic operators should always consult the latest published legislation and official guidance when placing CE-marked medical devices on the European market and maintaining ongoing compliance.
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