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CE Marking For System And Procedure Pack

CE Marking for Systems and Procedures

What are Systems and procedure packs ?

Systems and procedure packs are medical devices designed to be used in combination to aid specific medical procedures or interventions. These packs constitute multiple components and instruments necessary for a particular medical application, packaged together to streamline and facilitate the healthcare provider’s workflow. The goal is to ensure that all the required tools for a given medical procedure are conveniently assembled in a single pack, reducing the need for individual item selection during the procedure. Refer MDR, Article 2(10) and MDR, Article 2(11) respectively to note the definition of “Procedure pack” and “System”.

Examples of System And Procedure Pack:

1. Surgical Pack:

  • Components: Surgical drapes, gowns, gloves, scalpel, forceps, scissors, sutures, and other sterile items.
  • Application: Used for various surgical procedures, ensuring that surgical teams have all necessary tools in one pack.

2. Central Line Insertion Pack:

  • Components: Sterile drapes, gloves, central venous catheter, guidewire, syringes, antiseptic solution, dressings, and other items.
  • Application: Designed for the insertion of central venous catheters, providing a sterile and organized set of tools for the procedure.

3. Orthopedic Pack:

  • Components: Sterile drapes, surgical instruments (saws, drills, retractors), implants (plates, screws), gloves, and other orthopedic tools.
  • Application: Tailored for orthopedic surgeries, ensuring that orthopedic surgeons have the necessary instruments and implants.

4. Endoscopy Procedure Pack:

  • Components: Endoscope, trocars, forceps, snares, biopsy instruments, sterile drapes, and other accessories.
  • Application: Used for endoscopic procedures, providing endoscopists with a set of tools for diagnostic or therapeutic interventions.

5. Catheterization Pack:

  • Components: Catheters, guidewires, syringes, sterile drapes, gloves, and antiseptic solution.
  • Application: Designed for various catheterization procedures, providing a sterile and organized set of tools for healthcare providers.

6. Dental Procedure Pack:

  • Components: Dental instruments (mirror, probe, forceps), gloves, masks, and drapes.
  • Application: Used for dental procedures, ensuring that dental professionals have the necessary instruments for examinations or minor interventions.

7. Pacemaker Implantation System Pack:

    • Components: Pacemaker leads, pacemaker generator, suture materials, scalpel, and sterile drapes.
    • Application: Used in the implantation of pacemakers for cardiac pacing.

8. Labor and Delivery Pack:

  • Components: Sterile drapes, gloves, clamps, scissors, sutures, and other obstetric tools.
  • Application: Tailored for use during labor and delivery, providing obstetricians with essential tools for safe delivery.

These examples highlight the diversity of systems and procedure packs, each designed to meet the specific requirements of a particular medical procedure. The goal is to enhance efficiency, reduce the risk of contamination, and provide healthcare professionals with a standardized set of tools for safe and effective patient care.

However, it should be noted that these Systems and procedure packs may not necessarily be just medical devices but can also be combinations of Personal Protective Equipment Regulation (PPE) or in vitro diagnostic (IVD) devices compliant with the IVD Directive (IVDD) or Regulation (IVDR) with medical devices or any other device that may have a medical purpose. Alternatively, if a product does not have any medical intended use and is to be provided with the medical or IVD device by the manufacturer, the same can be considered as an accessory and must be CE marked.

How are Systems and Procedure Pack Producers different from Manufacturers?

Both Producers and Manufacturers have been distinctly identified in the regulation as “Economic operators” with individual roles and obligations.

According to the EU MDR, a “manufacturer” is broadly defined as any natural or legal person who manufactures or fully refurbishes a medical device or has a medical device designed, manufactured, or fully refurbished, and markets that device under their name or trade name.