‘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
“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.
Systems and procedure packs refer to pre-assembled sets of medical instruments, devices, and consumables designed for specific surgical or procedural needs. Examples include:
1. Surgical Procedure Packs – Sterile kits containing scalpels, forceps, drapes, and sutures for surgeries like orthopedic or cardiovascular procedures.
2. IV Start Packs – Includes tourniquets, antiseptic swabs, gauze, and catheters for intravenous therapy.
3. Wound Care Packs – Equipped with dressings, gloves, saline, and adhesive tapes for treating wounds.
4. Catheterization Packs – Contains catheters, lubricants, and disinfectants for urinary catheterization.
These packs enhance efficiency, reduce infection risk, and ensure procedural standardization.
“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.
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.
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:
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.
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.
“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.
According to MDR Article 22(5), the following labelling requirements apply to Systems/Procedure Packs:
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.
“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.”
“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.
System and procedure packs play a crucial role in enhancing efficiency, safety, and standardization in medical settings. By providing pre-assembled, sterile kits tailored for specific procedures, they reduce preparation time, minimize infection risks, and ensure all necessary tools are readily available. These packs improve workflow for healthcare professionals, allowing them to focus on patient care rather than gathering supplies. Additionally, they promote cost-effectiveness by reducing waste and optimizing resource utilization. As medical technology advances, the development of customized procedure packs will continue to enhance surgical precision, patient safety, and overall healthcare efficiency, making them indispensable in modern medicine.
Author – Radha Kalmegh
Recent Post
Impact of Usability Engineering in Medical Devices
Use of Artificial Intelligence in Medical Devices
Are You Looking For Medical Devices Certifications?
Contact Us