What is a System?
‘System’ means a combination of products, either packaged together or not, that are intended to be interconnected or combined to achieve a specific medical purpose. E.g.: X-ray system
What is a Procedure Pack?
“Procedure Pack” is a set of medical products that are grouped and sold together for a specific medical use. For example, this could include items like first aid kits, orthodontic packs, or skin traction kits. These packs are designed to make it easier for healthcare providers to have everything they need for a particular procedure in one convenient package.
CE Marking & CE Marking Symbol
“Systems and procedure packs” do not require an additional CE marking. Instead, they should display the name, registered trade name, or registered trademark of the person mentioned in paragraphs 1 and 3 of this Article, along with the address.
System/Procedure Pack Producers should keep the following documentation
- Content of the Procedure Pack
- Description of the products
- Labelling details, including instructions for use and implant cards if relevant
- Packaging information, including specifications and, if applicable, procedures for relabelling or repackaging
- Outline of the UDI procedure
- Verification of the compatibility of the included products, including any additional testing if needed
- Process for combining products
- Sterilization information if the Producer performs sterilization for market placement, including the Notified Body certificate
- The System/Procedure Pack Declaration where this person can be reached, to allow for the verification of their location.
The System/Procedure Pack statement and documentation must be retained for a period ranging from 5 to 10 years, or 15 years for implantable devices.
Classification of Systems and Procedure Packs
Systems and Procedure Packs themselves are not classified and do not have an individual risk classification.
However, manufacturers may still need to apply a risk classification for various reasons, such as:
- The EUDAMED registration database requires a classification to be recorded.
- To determine relevant MDR deadlines, such as when to include the UDI carrier on the labelling.
In these cases, the manufacturer should use the classification of the highest-risk device within the System/Procedure Pack.
Non-medical products may be included in a System/Procedure Pack.
EU Authorized Representative (EC Rep)
An EU Authorized Representative is not needed for System/Procedure Packs as defined under the MDR. Article 22 of the MDR does not mandate the appointment of an EU Authorized Representative for these packs.
If a System or Procedure Pack contains CE Marked medical devices, each device may have an EU Authorized Representative (EU AR) if the manufacturer is outside the EU. However, the entire System or Procedure Pack doesn’t need a separate EU Authorized Representative.
MDCG 2021-23
“Please note that SPPP [System/Procedure Pack Producers] located in a non-EU country do not have an obligation to designate an AR [Authorized Representative]. Therefore, the SPPP should consider providing additional relevant information to the CA [Competent Authority], in order to facilitate the verification of the data provided for the purpose of the registration request.”
The System/Procedure Pack Producer will be regarded as the importer for a non-EU manufacturer.
Labelling
According to MDR Article 22(5), the following labelling requirements apply to Systems/Procedure Packs:
- They must not display an additional CE marking.
- They must include the name, registered trade name, or registered trademark of the System/Procedure Pack Producer.
- The label must provide the address where the System/Procedure Pack Producer can be contacted, to establish their location.
- The label must contain the information specified in MDR Annex I(23) and/or IVDR Annex I(20).
- The UDI carrier must be included by the required deadline.
- If applicable, the expiration date must be based on the shortest shelf life of the components.
- A specific lot number must be present.
- Information on the packaging must preserve any sterile condition of the device.
- A list of components must be provided, either in the declaration, on the label, or in the instructions for use.
UDI & Basic UDI-DI
For System/Procedure Packs under the MDR, it’s essential to follow the UDI requirements. This includes obtaining a Basic UDI-DI, ensuring the UDI carrier is on the label, and registering in the EUDAMED UDI/Devices module. This process helps maintain compliance and ensures proper identification and traceability.
Per MDR Article 29(2)
“Before placing on the market, a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom-made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.”
And MDR Annex VI, Part C, 3.7
“Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.”
The System/Procedure Pack Producer is deemed a distributor, which have already been placed on the EU market.
References
