Systems & procedure packs
MDR Art. 22 governs systems and procedure packs — combinations of products that are assembled together for a specific medical purpose. The person assembling a system or procedure pack takes on specific regulatory obligations.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
What is a system or procedure pack?
System
A system is a combination of products — at least one of which is a medical device — that are packaged together and intended by the person assembling them (the assembler) to be used together for a specific medical purpose.
A system may combine:
- Multiple CE-marked medical devices
- A CE-marked medical device with other products (non-CE-marked sterile items, accessories, IVDs, or medicinal products) if they are compatible and fit for the intended purpose
Procedure pack
A procedure pack is a combination of products, including at least one CE-marked medical device, packed together to be used for a specific medical or surgical procedure and placed on the market for that single, defined purpose.
Key distinction from combination products
Systems and procedure packs are distinct from integral drug-device combinations (Art. 1(8)). In a system or procedure pack:
- Each component retains its own CE marking and regulatory status
- The assembler adds value by combining them — but does not create a new, single, integral product
- The assembler's regulatory obligations are limited to the act of combining (see below)
Who is the assembler?
The assembler is any natural or legal person who combines devices and/or other products into a system or procedure pack and places it on the market. The assembler may be:
- A hospital or healthcare institution that creates its own procedure packs for use in procedures
- A commercial entity that assembles and sells pre-packaged surgical kits
- A manufacturer who combines their own device with accessories or complementary products
Assembler obligations — MDR Art. 22
The assembler of a system or procedure pack must:
1. Verify component compatibility
Verify that the devices and other products included are:
- CE marked (or otherwise lawfully on the market, where applicable)
- Compatible with each other — no adverse interactions
- Fit for the intended purpose of the system/procedure pack
- Within their stated shelf life (if sterile components are included)
2. Prepare and keep documentation
The assembler must prepare documentation stating:
- The CE marking status of each component
- That the components are mutually compatible
- The intended purpose of the system/procedure pack
- The identity of the assembler
This documentation must be made available to competent authorities on request.
3. Provide a statement of CE marking status
The assembler must not affix a new CE mark to the system — the individual components' CE marks remain valid. Instead, the system as a whole is accompanied by a statement that:
- Components bear CE markings
- Components are mutually compatible
4. Provide appropriate labelling and IFU
The system/procedure pack must have labelling that:
- Identifies the assembler
- Identifies the system/procedure pack clearly
- References the CE certificates of the component devices
Sterile procedure packs
If the assembler sterilises the system or procedure pack (combining already-CE-marked components into a newly sterilised package), additional obligations apply:
- The sterilisation process must be validated
- The sterile pack must be labelled with the assembler's details and the batch number / sterilisation information
- The assembler must implement a quality management system covering the sterilisation process
- The assembler must involve a notified body for the sterility aspects (similar to Class Is device obligations)
What the assembler does NOT do
The assembler does not:
- Modify any of the component devices (this would make them a manufacturer of a new device)
- Create a new product with an integral design — the components remain separable
- Affix a new CE mark to the system as a whole
- Take on full manufacturer responsibility for the individual component devices
If the assembler modifies a component device in any way that could affect its safety or performance, they become the manufacturer of that modified device and must comply with all MDR manufacturer obligations.
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 22 | Systems and procedure packs |
| MDR Art. 2(11) | Definition of "placing on the market" (relevant for assemblers) |
| MDR Art. 16 | Persons responsible when product does not bear CE mark |
| MDCG 2022-4 | Guidance on systems and procedure packs |