Kits

The Medical Devices Directive refers to two specific manners of placing medical devices together under a single packaging onto the European Market:

“Systems” or “Procedure Packs” (MDD 93/42/EEC Article 12);


Procedure Packs

A  “procedure pack” can be defined as an assembly of medical devices that  are packed together and sold on the market with the intention of being used during procedures (e.g., surgical procedure) or medical treatment.

The  devices in the “procedure pack” are not required to be used in  combination or at the same time. Moreover, the manufacturer of the  procedure pack may be the manufacturer of all the devices from the  procedure pack, or may put in the procedure pack devices having  different manufacturers.


Example of procedure packs:

  • First aid kits
  • Packs for specific surgical procedure
  • Orthodontic procedure packs

Systems

A  “system” can be defined as an assembly of medical devices that are  designed to be used solely in combination one with the other, and cannot  achieve the claimed medical intended purpose alone (see scope of a  medical device).


Examples of systems:

  • Prosthetic system
  • Joint replacement system

Please  note that a “system” or “procedure pack” (KITs) comprising medical  devices, all devices must undergo individual conformity assessment  procedures and bear the CE marking individually while the KIT itself will not be CE marked;


Steps to Place KITS on the EU Market

Step 1: Compliance with all the essential safety & health requirements that apply to the device (seecompliancewith the MDD 93/42/EEC);

  • Comply with the essential requirements (MDD 93/42/EEC Annex I);
  • Technical documentation (MDD 93/42/EEC Annex VIII Point 3.1) ;
  • Vigilance system;

Step 2: Non-EU Manufacturer appointing an Authorized Representative in Europe;

Step 3: Notification the Competent Authority of the intention of placing a Medical Kit (“System” or “Procedure Pack” onto the European Market ( MDD 93/42/EEC Article 12));


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