Updated: 24th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder & CEO)
What Are Medical Device Systems and Procedure Packs?
Medical device systems and procedure packs are combinations of medical devices and, in some cases, other products that are assembled together to achieve a specific clinical purpose. Rather than purchasing individual components separately, healthcare providers often use systems or procedure packs that have been prepared in advance to improve efficiency, standardise clinical procedures and reduce the risk of errors during patient care.
Although the terms are often used interchangeably, systems and procedure packs have distinct meanings under the EU Medical Device Regulation (EU MDR 2017/745). Understanding the difference is essential because the regulatory requirements, responsibilities and obligations under Article 22 apply to both, but the way they are assembled and used can differ.
What Is a Medical Device System?
A medical device system is a combination of CE-marked medical devices, and where appropriate other compatible products, that are intended to work together to achieve a common medical purpose. The individual components remain separate devices but function as an integrated system during clinical use.
Examples of medical device systems include:
- An infusion pump connected to compatible administration tubing and infusion sets.
- A patient monitoring system comprising a monitor, sensors and associated accessories.
- An endoscopy system including the endoscope, camera head, light source and display monitor.
- A surgical navigation system incorporating multiple compatible hardware and software components.
In these cases, the individual devices are intended to operate together while retaining their original intended purpose.
What Is a Procedure Pack?
A procedure pack is a collection of medical devices that are packaged together for use during a specific medical or surgical procedure. Unlike a medical device system, the products within a procedure pack do not necessarily function together as an integrated device. Instead, they are supplied together to provide clinicians with all the components needed to perform a particular procedure efficiently.
Typical examples include:
- Minor surgery packs.
- Wound dressing kits.
- Catheterisation packs.
- Ophthalmic procedure packs.
- Dental treatment packs.
- Orthopaedic procedure packs.
A procedure pack may contain sterile and non-sterile components, provided they are assembled and supplied in accordance with the requirements of Article 22.
Why Does Article 22 Exist?
Article 22 recognises that combining CE-marked devices into systems or procedure packs can improve clinical efficiency without necessarily creating a new medical device. Instead of requiring every system or procedure pack producer to undergo the full conformity assessment process applicable to manufacturers, the MDR allows these combinations to be placed on the market under a separate regulatory framework, provided specific conditions are met.
Those conditions include ensuring that the individual devices are compatible, used in accordance with their intended purpose, accompanied by the appropriate information supplied by the original manufacturers and assembled without compromising their safety or performance.
Where these conditions are no longer met—for example, if the products are modified, sterilised incorrectly or combined in a way that changes their intended purpose—the organisation assembling the system or procedure pack may assume the responsibilities of a medical device manufacturer under the MDR.
New to the EU MDR?
System and procedure packs are regulated under Article 22 of Regulation (EU) 2017/745. For a complete overview of MDR requirements, including classification, Article 10 obligations, GSPRs, technical documentation, UDI, EUDAMED and CE marking, explore our EU MDR for Beginners Guide.
When Does Article 22 of the EU MDR Apply?
Article 22 of the EU Medical Device Regulation (EU MDR 2017/745) establishes the legal framework for organisations that combine CE-marked medical devices, and in certain cases other compatible products, into systems or procedure packs before placing them on the European market. Rather than treating every combination as a new medical device, Article 22 allows these products to be supplied under a separate regulatory pathway, provided specific conditions are satisfied.
The purpose of Article 22 is to ensure that combining compliant products does not compromise their safety, performance or intended purpose while avoiding unnecessary duplication of conformity assessment activities.
Conditions That Must Be Met
For Article 22 to apply, the person assembling the system or procedure pack must ensure that:
- All medical devices included within the system or procedure pack bear a valid CE mark where required by the MDR or IVDR.
- The devices are combined in a manner that is compatible with their intended purpose and the intended use specified by their original manufacturers.
- The combination of products does not adversely affect the safety, performance or clinical effectiveness of any component.
- The assembly process follows the instructions and information provided by the original manufacturers.
- Appropriate information, including the relevant Instructions for Use (IFUs), is supplied with the completed system or procedure pack where required.
- The assembly and verification activities are documented and performed using suitable internal procedures.
Where these conditions are met, the assembler does not generally become the legal manufacturer of a new medical device and may place the system or procedure pack on the market in accordance with Article 22.
When Does Article 22 No Longer Apply?
Article 22 cannot be relied upon if the assembler goes beyond simply combining compatible CE-marked products. If the system or procedure pack is modified in a way that changes the characteristics, intended purpose or regulatory status of the included devices, additional MDR requirements are likely to apply.
Examples include:
- Modifying the design or function of a medical device.
- Combining products in a way that is not supported by the manufacturers’ intended purpose.
- Sterilising devices where the original manufacturer has not intended them to be re-sterilised or supplied sterile.
- Reprocessing single-use medical devices without complying with the applicable regulatory requirements.
- Making changes that could affect the safety, performance or clinical effectiveness of the products.
In these situations, the organisation assembling the products may assume the legal responsibilities of a medical device manufacturer and become subject to the full requirements of the MDR, including conformity assessment, Technical Documentation and Post-Market Surveillance obligations.
Understanding the Regulatory Boundary
The key principle of Article 22 is that it facilitates the safe assembly of compatible CE-marked products without creating unnecessary regulatory burdens. However, this simplified approach only applies while the original devices remain unchanged and continue to be used in accordance with their intended purpose.
Before placing a system or procedure pack on the market, organisations should carefully assess whether their activities remain within the scope of Article 22 or whether they have crossed the threshold into manufacturing a new medical device under the MDR.
Responsibilities of a System and Procedure Pack Producer
Organisations that assemble medical device systems or procedure packs under Article 22 of the EU MDR have specific legal responsibilities before placing their products on the European market. Although they do not normally become the legal manufacturer of a new medical device, they must demonstrate that the system or procedure pack has been assembled in accordance with the requirements of Article 22 and that the safety and performance of the included devices have not been compromised.
These responsibilities help ensure that healthcare professionals receive systems and procedure packs that are safe, correctly assembled and supported by the appropriate regulatory documentation.
Verify Compatibility
Before assembling a system or procedure pack, the producer should verify that the included devices are compatible with one another and are intended by their original manufacturers to be used together where applicable.
This includes reviewing:
- The intended purpose of each device.
- Manufacturer Instructions for Use (IFUs).
- Compatibility statements.
- Operating limitations.
- Environmental or performance requirements.
Any incompatibility that could affect the safety or performance of the products should be identified and addressed before the system or procedure pack is placed on the market.
Assemble the Products Correctly
The producer must ensure that assembly is performed in accordance with the instructions provided by the original manufacturers.
Assembly procedures should be documented and controlled to ensure consistency and reduce the risk of assembly errors that could affect device performance or patient safety.
Supply the Required Information
Systems and procedure packs must be supplied with all information necessary for their safe use. This may include:
- Instructions for Use.
- Warnings and precautions.
- Storage conditions.
- Traceability information.
- Details of the producer.
- Information required by Article 22.
Healthcare professionals should receive sufficient information to use every component safely and as intended.
Maintain Records
Producers should maintain records demonstrating compliance with Article 22, including:
- Verification of device compatibility.
- Assembly procedures.
- Component traceability.
- Supplier information.
- Quality control activities.
- Distribution records.
These records provide evidence of compliance and support investigations should complaints or regulatory inspections occur.
Implement Appropriate Quality Controls
Although Article 22 does not explicitly require ISO 13485 certification, producers should operate documented procedures to ensure systems and procedure packs are assembled consistently and in accordance with regulatory requirements.
Effective quality controls typically include:
- Incoming inspection of components.
- Assembly verification.
- Packaging checks.
- Labelling verification.
- Final release inspection.
- Document control.
Implementing robust quality processes helps minimise errors and demonstrates that the producer has exercised appropriate control over the assembly process.
Prepare the Article 22 Statement
One of the most important obligations under Article 22 is preparing the required statement confirming that:
- Compatibility between the products has been verified.
- Assembly has been carried out in accordance with the manufacturers’ instructions.
- The system or procedure pack has been assembled without compromising the safety or performance of the included devices.
- Appropriate internal monitoring and verification activities have been completed.
This statement forms an important part of demonstrating compliance with Article 22 and should be retained as part of the producer’s regulatory documentation.
When Does a System or Procedure Pack Become a New Medical Device?
One of the most important considerations when assembling a medical device system or procedure pack is determining whether the activities remain within the scope of Article 22 or whether they create a new medical device under the EU Medical Device Regulation (EU MDR 2017/745).
In many cases, simply combining compatible CE-marked medical devices into a system or procedure pack does not create a new medical device. Article 22 specifically allows these products to be placed on the market without the assembler assuming the full legal responsibilities of a manufacturer, provided all of the Article 22 conditions are satisfied.
However, if the assembler goes beyond these permitted activities, they may become the legal manufacturer of a new medical device and must comply with all applicable MDR requirements.
Activities That May Create a New Medical Device
The assembler may become the manufacturer if they:
- Modify the design or functionality of one or more medical devices.
- Change the intended purpose specified by the original manufacturer.
- Combine products in a manner that is not supported by the manufacturers’ Instructions for Use.
- Introduce new software or hardware that alters device performance.
- Sterilise products that were not intended to be supplied sterile or use an unvalidated sterilisation process.
- Reprocess single-use devices without complying with the applicable regulatory requirements.
- Make changes that could affect the safety, performance or clinical effectiveness of the assembled products.
In these situations, the system or procedure pack may no longer qualify under Article 22 and instead be regarded as a new medical device requiring its own conformity assessment.
What Happens If You Become the Manufacturer?
Where a new medical device is created, the organisation assembling the products assumes the legal responsibilities of a manufacturer under the MDR. These responsibilities typically include:
- Determining the appropriate device classification.
- Implementing and maintaining a compliant Quality Management System.
- Preparing complete Technical Documentation in accordance with Annexes II and III.
- Demonstrating compliance with the General Safety and Performance Requirements (GSPRs).
- Conducting Clinical Evaluation where required.
- Implementing Risk Management in accordance with ISO 14971.
- Completing the appropriate conformity assessment procedure.
- Obtaining Notified Body certification where applicable.
- Establishing Post-Market Surveillance and vigilance processes.
These obligations are significantly more extensive than those placed on a system or procedure pack producer operating solely under Article 22.
Need to Prepare a Compliant Technical File?
If your activities fall outside the scope of Article 22, you may need to prepare full MDR Technical Documentation. Learn how to structure a compliant medical device Technical File, including Annex II and Annex III documentation, GSPRs, Risk Management, Clinical Evaluation and Post-Market Surveillance in our Complete Guide to Medical Device Technical Files.
Assess Changes Carefully Before Placing Products on the Market
Even seemingly minor modifications can have regulatory consequences. Organisations should carefully assess any proposed changes to a system or procedure pack before placing it on the market, considering whether those changes could affect the intended purpose, safety, performance or regulatory status of the included devices.
Where uncertainty exists, seeking regulatory advice before implementing changes can help avoid unintentionally assuming the responsibilities of a medical device manufacturer.
Article 22 or a New Medical Device?
Determining whether your activities remain within the scope of Article 22 is one of the most important regulatory assessments when assembling medical device systems and procedure packs. In general, Article 22 applies where CE-marked devices are combined without altering their intended purpose, safety or performance. However, once modifications are made that affect how the products function or are intended to be used, the assembler may assume the legal responsibilities of a manufacturer under the MDR.
The table below summarises some common activities and whether they are likely to remain within the scope of Article 22.
| Activity | Article 22 Applies? | Explanation |
|---|---|---|
| Assemble compatible CE-marked medical devices according to the manufacturers’ Instructions for Use | ✅ Yes | The products are combined without changing their intended purpose or performance. |
| Package CE-marked devices together for a specific clinical procedure | ✅ Yes | Procedure packs assembled for clinical convenience are permitted under Article 22 where all conditions are met. |
| Verify compatibility between the included devices | ✅ Yes | Producers are expected to confirm that the products are suitable for use together. |
| Prepare and retain the required Article 22 Statement | ✅ Yes | This is one of the producer’s key legal responsibilities under Article 22. |
| Supply the manufacturers’ Instructions for Use and required information | ✅ Yes | Users must receive the information necessary to use the products safely and effectively. |
| Modify the intended purpose of a medical device | ❌ No | Changing the intended purpose may create a new medical device and the assembler may become the manufacturer. |
| Alter the design or functionality of a medical device | ❌ No | Design modifications fall outside the scope of Article 22 and are subject to the full MDR requirements. |
| Combine products in a manner not supported by the original manufacturers | ❌ No | The compatibility and intended use of the products can no longer be relied upon. |
| Re-sterilise or sterilise devices using an unvalidated process | ❌ No | Changes to sterility may create additional regulatory obligations and may result in manufacturer responsibilities. |
| Make changes that affect the safety or performance of the assembled products | ❌ No | If safety or performance is altered, the combination is unlikely to remain within the scope of Article 22. |
The Key Principle
The central principle of Article 22 is that organisations may assemble compatible CE-marked medical devices into systems or procedure packs without becoming the legal manufacturer, provided they do not modify the devices or compromise their intended purpose, safety or performance. Once those conditions are no longer met, the organisation may assume the full regulatory obligations of a manufacturer under the EU MDR, including conformity assessment, Technical Documentation, Quality Management System requirements and ongoing Post-Market Surveillance.
Become the Manufacturer? Understand CE Marking Requirements
If your system or procedure pack no longer falls within the scope of Article 22, you may assume the legal responsibilities of a medical device manufacturer. Learn how the EU CE marking process works, including device classification, conformity assessment, Technical Documentation, Notified Body involvement and ongoing compliance in our Complete Guide to CE Marking Medical Devices.
How to Achieve Compliance with Article 22
Complying with Article 22 requires more than simply assembling CE-marked medical devices into a system or procedure pack. Producers should establish documented procedures to ensure that every system or procedure pack is assembled consistently, supported by appropriate evidence and placed on the market in accordance with the requirements of the EU MDR.
Although the exact process will vary depending on the complexity of the products involved, most organisations should follow a structured compliance workflow.
Step 1 – Identify the Components
Begin by identifying every medical device and other product that will form part of the system or procedure pack.
For each component, confirm:
- The manufacturer.
- The intended purpose.
- CE marking status.
- Applicable Instructions for Use.
- Storage and handling requirements.
- Any compatibility limitations specified by the manufacturer.
This information forms the basis of the compatibility assessment.
Step 2 – Assess Compatibility
Before combining products, verify that the included devices are intended to be used together and that their combination will not adversely affect safety or performance.
The assessment should consider:
- Intended purpose.
- Physical compatibility.
- Functional compatibility.
- Clinical compatibility.
- Environmental limitations.
- Sterility considerations.
- Any manufacturer restrictions.
Documenting this assessment demonstrates that appropriate due diligence has been performed.
Step 3 – Assemble the System or Procedure Pack
The products should be assembled in accordance with documented procedures and the manufacturers’ Instructions for Use.
Where packaging is undertaken, producers should ensure:
- Components are correctly identified.
- Packaging maintains product integrity.
- Sterile barrier systems remain effective where applicable.
- Packaging materials are suitable for transport and storage.
Consistency during assembly reduces the likelihood of errors reaching the end user.
Step 4 – Prepare the Article 22 Documentation
Before placing the system or procedure pack on the market, producers should prepare the documentation required by Article 22.
This typically includes:
- Compatibility assessment records.
- Assembly procedures.
- Verification activities.
- Traceability records.
- Labelling information.
- The Article 22 Statement.
- Quality control records.
Maintaining organised documentation makes regulatory inspections significantly easier.
Step 5 – Verify Before Release
Before distribution, every system or procedure pack should undergo a final verification process to confirm that:
- The correct components have been included.
- Packaging is complete and undamaged.
- Labelling is accurate.
- Required documentation accompanies the product.
- Traceability records have been completed.
A documented release process helps demonstrate that the producer has exercised appropriate regulatory control.
Step 6 – Maintain Ongoing Compliance
Compliance does not end once the product has been placed on the market.
Producers should continue to:
- Investigate complaints.
- Monitor customer feedback.
- Maintain traceability records.
- Review compatibility where components change.
- Update documentation where necessary.
- Cooperate with Competent Authorities if required.
Maintaining these activities helps ensure that systems and procedure packs continue to meet the requirements of Article 22 throughout their lifecycle.
Need to Understand ISO 13485?
Although ISO 13485 certification is not explicitly required for every system and procedure pack producer under Article 22, implementing a robust Quality Management System can help ensure consistent assembly, document control, traceability and regulatory compliance. Learn more about the requirements of ISO 13485 and how it supports medical device manufacturers in our Complete Guide to ISO 13485.
Common Examples of Medical Device Systems and Procedure Packs
Medical device systems and procedure packs are used throughout healthcare to improve efficiency, standardise clinical procedures and ensure that all necessary components are available when required. While the exact contents vary depending on the intended clinical application, all systems and procedure packs placed on the market under Article 22 should be assembled in a manner that maintains the safety, performance and intended purpose of the included devices.
The examples below illustrate some of the most common systems and procedure packs encountered in clinical practice.
| Example | Typical Components | System or Procedure Pack? |
|---|---|---|
| Minor Surgery Pack | Scalpel, forceps, scissors, drapes, gauze, syringes, gloves and dressings | Procedure Pack |
| Catheterisation Pack | Catheter, syringes, lubricant, drapes, gloves, specimen container and antiseptic swabs | Procedure Pack |
| Wound Care Kit | Dressings, sterile gauze, adhesive tapes, cleansing solution and disposable instruments | Procedure Pack |
| Ophthalmic Procedure Pack | Eye drapes, speculum, syringes, cannulas, surgical blades and sterile dressings | Procedure Pack |
| Dental Treatment Pack | Dental mirrors, probes, cotton rolls, suction tips, syringes and disposable accessories | Procedure Pack |
| Infusion Therapy System | Infusion pump, administration tubing, connectors, infusion sets and compatible accessories | Medical Device System |
| Patient Monitoring System | Patient monitor, ECG leads, SpO₂ sensor, blood pressure cuff and temperature probe | Medical Device System |
| Endoscopy System | Endoscope, camera head, light source, processor and display monitor | Medical Device System |
| Orthopaedic Navigation System | Navigation console, tracking sensors, software, instruments and compatible accessories | Medical Device System |
Why the Distinction Matters
Although both systems and procedure packs are regulated under Article 22, they are assembled for different reasons.
A procedure pack brings together products required to perform a particular medical procedure, allowing clinicians to access all necessary components in a single package. The individual devices are generally used independently during the procedure and do not rely on one another to function.
A medical device system, on the other hand, consists of devices that are intended to operate together as an integrated solution. Each component contributes to the overall function of the system, meaning compatibility between devices is particularly important to ensure safe and effective performance.
Understanding this distinction helps producers determine the appropriate assembly process, assess compatibility correctly and demonstrate compliance with Article 22 before placing their products on the market.
Common Compliance Mistakes When Assembling Systems and Procedure Packs
Although Article 22 provides a practical regulatory framework for assembling medical device systems and procedure packs, organisations frequently make mistakes that can result in non-compliance with the EU MDR. Many of these issues arise from misunderstanding the limits of Article 22 or assuming that combining CE-marked medical devices automatically removes the need for regulatory oversight.
By understanding the most common pitfalls, producers can reduce regulatory risk and help ensure that their systems and procedure packs continue to comply with the MDR.
Assuming CE-Marked Devices Can Always Be Combined
One of the most common misconceptions is that any CE-marked medical devices can be assembled into a system or procedure pack. In reality, producers must verify that the devices are compatible and intended to be used together where appropriate.
Simply because two products are CE marked does not guarantee that their combined use is safe or supported by the original manufacturers.
Modifying Devices During Assembly
Article 22 applies only where devices are assembled without altering their intended purpose, safety or performance.
Examples of modifications that may result in the producer becoming the legal manufacturer include:
- Altering device functionality.
- Changing software or hardware.
- Reconfiguring products beyond the manufacturer’s instructions.
- Modifying packaging in a way that affects sterility or performance.
Before making any changes, producers should carefully assess whether the activities remain within the scope of Article 22.
Failing to Prepare the Article 22 Statement
The Article 22 Statement is a key regulatory requirement but is sometimes overlooked.
Without this documentation, organisations may struggle to demonstrate that they have:
- Verified compatibility.
- Followed the manufacturers’ Instructions for Use.
- Assembled the products correctly.
- Confirmed that safety and performance have not been compromised.
Maintaining complete documentation is essential during regulatory inspections and audits.
Poor Traceability
Every component included within a system or procedure pack should be traceable throughout its lifecycle.
Producers should maintain records of:
- Manufacturers.
- Batch or lot numbers.
- Assembly records.
- Distribution records.
- Complaints.
- Corrective actions where applicable.
Effective traceability supports investigations, recalls and Post-Market Surveillance activities.
Incorrect Labelling
Incomplete or inaccurate labelling can create confusion for healthcare professionals and increase the risk of misuse.
Before placing a system or procedure pack on the market, producers should verify that:
- Labels are accurate.
- Required information is provided.
- Instructions accompany the product where necessary.
- The producer is correctly identified.
- Any additional Article 22 information has been included.
Treating Article 22 as a One-Time Exercise
Compliance does not end once a system or procedure pack has been placed on the market.
Organisations should regularly review their procedures to ensure that:
- Components have not changed.
- Manufacturers have not updated their Instructions for Use.
- Regulatory requirements remain satisfied.
- Complaints and customer feedback are reviewed.
- Documentation is kept up to date.
Ongoing review helps ensure continued compliance throughout the product lifecycle.
Building Compliance into Your Processes
Most Article 22 non-conformities are avoidable. By implementing documented procedures, maintaining accurate records and regularly reviewing systems and procedure packs against the requirements of the EU MDR, producers can minimise regulatory risk and demonstrate a robust approach to compliance.
Rather than viewing Article 22 as a simple packaging exercise, organisations should treat it as an integral part of their quality and regulatory management system. This helps ensure that systems and procedure packs continue to be assembled safely, consistently and in accordance with the expectations of regulators and healthcare providers alike.
Post-Market Responsibilities for System and Procedure Pack Producers
Placing a system or procedure pack on the market is not the end of a producer’s regulatory responsibilities. Although Article 22 provides a simplified framework for assembling compatible CE-marked medical devices, producers remain responsible for ensuring that their systems and procedure packs continue to meet the applicable requirements of the EU MDR throughout their lifecycle.
Maintaining effective post-market processes helps identify potential issues, supports patient safety and demonstrates ongoing compliance during regulatory inspections.
Monitor Product Performance
Producers should establish procedures to monitor the performance of their systems and procedure packs once they have been placed on the market. Information may be collected from a variety of sources, including:
- Customer feedback.
- Complaints.
- Distributor reports.
- Healthcare professionals.
- Internal quality reviews.
- Regulatory notifications.
Reviewing this information enables producers to identify recurring issues and determine whether corrective action is required.
Investigate Complaints
All complaints relating to a system or procedure pack should be documented, investigated and evaluated.
Where appropriate, investigations should determine:
- The root cause of the issue.
- Whether the problem relates to an individual component or the assembled pack.
- Whether similar products may be affected.
- Whether corrective or preventive actions are required.
Complaint handling procedures should be documented and integrated into the organisation’s Quality Management System where applicable.
Maintain Traceability Records
Traceability remains essential throughout the lifecycle of a system or procedure pack.
Producers should retain records of:
- Components used.
- Manufacturers.
- Batch and lot numbers.
- Assembly records.
- Distribution records.
- Customer complaints.
- Corrective actions.
Accurate records enable rapid investigations and support any necessary field actions.
Review Changes to Included Devices
Medical device manufacturers may update their products over time by changing labelling, Instructions for Use, technical specifications or intended purpose.
Whenever a component within a system or procedure pack changes, producers should assess whether:
- Compatibility remains acceptable.
- Existing assembly procedures remain valid.
- Labelling requires updating.
- The Article 22 Statement should be reviewed.
- Additional verification activities are necessary.
Regular reviews help ensure continued compliance with Article 22.
Cooperate with Competent Authorities
If requested, producers should be able to provide evidence demonstrating compliance with Article 22, including:
- Compatibility assessments.
- Assembly procedures.
- The Article 22 Statement.
- Traceability records.
- Complaint investigations.
- Corrective actions.
Maintaining organised documentation makes regulatory inspections significantly more straightforward.
Continual Improvement
Effective post-market activities should feed back into the organisation’s quality processes. Reviewing complaints, monitoring trends and updating procedures where necessary helps ensure that systems and procedure packs continue to be assembled safely, consistently and in accordance with the latest regulatory expectations.
By adopting a proactive approach to post-market activities, producers can strengthen compliance, improve product quality and maintain confidence among healthcare professionals, regulators and patients alike.
Need to Understand Post-Market Surveillance?
Post-Market Surveillance (PMS) is an ongoing requirement under the EU MDR and plays a vital role in maintaining the safety, performance and regulatory compliance of medical devices throughout their lifecycle. Learn how to develop compliant PMS Plans, investigate complaints, manage vigilance activities and maintain ongoing compliance in our Complete Guide to Medical Device Post-Market Surveillance.
Conclusion
Medical device systems and procedure packs provide healthcare organisations with an efficient way to supply compatible medical devices for specific clinical procedures or integrated medical applications. Article 22 of the EU Medical Device Regulation (EU MDR 2017/745) allows these products to be placed on the market under a dedicated regulatory framework, provided they are assembled without compromising the intended purpose, safety or performance of the included devices.
Understanding the distinction between a medical device system and a procedure pack, verifying compatibility, preparing the required Article 22 Statement and maintaining appropriate quality and traceability records are all fundamental responsibilities for producers. Organisations should also recognise the point at which modifications or changes may result in them becoming the legal manufacturer of a new medical device, bringing with it the full requirements of the MDR.
By implementing robust assembly procedures, maintaining comprehensive documentation and continually reviewing post-market information, producers can demonstrate compliance with Article 22 while supporting the safe and effective use of medical devices throughout their lifecycle.
Frequently Asked Questions About System & Procedure Packs under EU MDR
A medical device system is a combination of CE-marked medical devices, and where appropriate other compatible products, that are intended to work together to achieve a common medical purpose. The individual devices remain separate products but function together as an integrated system. Medical device systems are regulated under Article 22 of the EU Medical Device Regulation (EU MDR 2017/745).
A procedure pack is a collection of medical devices packaged together for use during a specific medical or surgical procedure. Unlike a medical device system, the individual devices are not necessarily functionally connected but are supplied together to improve efficiency and ensure all required components are available for a particular clinical procedure.
Article 22 of the EU MDR establishes the regulatory requirements for organisations that assemble CE-marked medical devices into systems or procedure packs. It specifies the conditions that must be met before these products can be placed on the European market without the assembler becoming the legal manufacturer of a new medical device.
The individual medical devices included within a system or procedure pack should already bear a CE mark where required by the MDR or IVDR. Where the conditions of Article 22 are met, the producer assembles compliant products under the Article 22 framework rather than obtaining a separate CE mark for the completed system or procedure pack as a new medical device.
Yes. Article 22 allows medical devices from different manufacturers to be combined into a system or procedure pack, provided the devices are compatible, used in accordance with their intended purpose and assembled without compromising their safety or performance. Producers should verify compatibility and document their assessment before placing the system or procedure pack on the market.
A system or procedure pack may become a new medical device if the assembler modifies the included devices, changes their intended purpose, affects their safety or performance, or carries out activities that fall outside the conditions of Article 22. In these cases, the assembler may assume the legal responsibilities of a manufacturer under the EU MDR.
The Article 22 Statement is a declaration prepared by the producer confirming that the system or procedure pack has been assembled in accordance with Article 22 of the EU MDR. It confirms that compatibility has been verified, assembly has followed the manufacturers’ instructions and the safety and performance of the included devices have not been compromised.
Article 22 does not explicitly require producers to be certified to ISO 13485. However, implementing a Quality Management System based on ISO 13485 is considered best practice because it helps ensure consistent assembly, document control, traceability and regulatory compliance.
Producers should maintain records demonstrating compliance with Article 22, including compatibility assessments, assembly procedures, the Article 22 Statement, traceability records, supplier information, complaint investigations, quality control activities and distribution records. These documents support regulatory inspections and ongoing compliance.
Producers should continue to monitor complaints, maintain traceability records, investigate incidents, review changes to included devices and update their documentation where necessary. Maintaining effective post-market processes helps ensure continued compliance with Article 22 and supports the safe use of medical devices throughout their lifecycle.
References
This guide is based on the following legislation and official regulatory guidance relating to medical device systems and procedure packs under Regulation (EU) 2017/745 (MDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Contains Article 22, which establishes the legal framework for assembling CE-marked medical devices into systems and procedure packs, together with the associated obligations and conditions for placing them on the European market. |
| European Commission | MDCG Endorsed Documents and Other Guidance | Provides official Medical Device Coordination Group (MDCG) guidance supporting implementation of the MDR, including guidance relevant to Article 22, conformity assessment, technical documentation and post-market obligations. |
| European Commission | Notified Bodies for Medical Devices | Explains the role of Notified Bodies where activities performed on systems or procedure packs result in the organisation assuming the responsibilities of a medical device manufacturer requiring conformity assessment. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Defines the internationally recognised Quality Management System requirements supporting document control, traceability, assembly procedures, verification activities and ongoing regulatory compliance for system and procedure pack producers. |
| European Commission | EUDAMED – European Database on Medical Devices | Provides official information on EUDAMED and the wider regulatory framework supporting traceability, market surveillance and the lifecycle management of medical devices placed on the European market. |
Requirements relating to medical device systems and procedure packs continue to evolve through legislation and regulatory guidance. Organisations assembling systems and procedure packs should always consult the latest published legislation and official guidance when determining whether their activities remain within the scope of Article 22 or result in the responsibilities of a medical device manufacturer.
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