UDI for systems and procedure packs: Example added to MDCG Guidance

The MDCG updated its 2018-3 Guidance on UDI for systems and procedure packs, and added the below, highlighted example to the exemption under Section 3.2 of the Guidance.

Exemption with regard to “system or procedure pack producer”  – Article 22(1), 22(2) and 22(3) of the MDR

Based on a request of a client or hospital, a natural or legal person in the supply chain may make available together different products, including CE marked devices, which are – in that entire combination – neither placed on the market by that natural or legal person, nor intended by that natural or legal person to be used together for a specific medical purpose. Devices made available in the described manner are not considered as systems or procedure packs in accordance with the relevant definitions provided in Article 2 of the MDR. In this case, that natural or legal person is not regarded to be a system or procedure pack producer in accordance with Article 22.1, and is considered to be a distributor as per Article 2(34) of the MDR. It is to be noted that an importer may also make available devices to a client or hospital, in such manner.

Example 1: a distributor supplies, upon request of a client, in one shipment, sterile tweezers, a sterile needle and surgery gloves.

Example 2: Multi-device surgical sets comprised of individual devices delivered in trays for replenishment and sterilization for the request and for convenience of the healthcare provider and the healthcare system.

Under the conditions set in Article 22(4), systems and procedure packs are to be treated as devices in their own right and the related natural or legal persons shall assume the obligations incumbent on manufacturers. This specific scenario is out of the scope of the present guidance. Manufacturers of such devices shall refer to general guidance on UDI…”

The original MDCG Guidance can be found under UDI icon in our Library of documents.

Leave a Reply

Your email address will not be published.