Kits: MDD 93/42/EEC

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);

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.

Examples of procedures packs:

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

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).

Example 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 a KITS on the EU market

Step 1.

Compliance with all the essential safety & health requirements that apply to the device (see compliance with 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));