When the medical device incorporates:

• a substance that can be considered medicine when separated.
• whether or not derived from human blood or plasma.
• and that it has an accessory action.

The quality, safety, and usefulness of the substance will be verified as required for this type of substance.

After said verification and before issuing the certificate, the notified body, taking into account the intended purpose, will request a scientific opinion from one of the health authorities designated by the member states. The consultation will be about:

• the quality and quantity of the substance.
• the benefit/riskratio of the substance.

The manufacturing process and existing data will be taken into account by the authority consulted.

A scientific opinion will be issued within 210 days from receipt of the documentation.

Know more: www.i3cglobal.com/medical-device-composed-of-substances/

PROCEDURE IN THE CASE OF PRODUCTS THAT USE OR CARRY CELLS OR TISSUE OF HUMAN OR ANIMAL ORIGIN

When they have an accessory action to that of the product itself, the notified body, before issuing the EU certificate, after reviewing the technical documentation, will request a scientific report on:

• aspects related to the donation, collection, and analysis of cells or tissues.

The notified body will then submit a summary of the preliminary conformity assessment, which will introduce the feasibility and benefit/risk of the substance.

A notified opinion will be issued within 120 days.

PROCEDURE IN THE CASE OF PRODUCTS THAT USE OR CARRY CELLS OR TISSUE OF ANIMAL ORIGIN

In the case of non-viable elements by EU Regulation 722/2012, the notified body will apply the requirements described by the Regulation.

PROCEDURE IN THE CASE OF PRODUCTS THAT ARE DESIGNED TO BE INTRODUCED INTO THE BODY THROUGH A NATURAL ORIFICE

The quality and safety of the substances will be verified with the requirements specified in Annex I of Directive 2001/83 / EC .

In addition, when the products of its metabolism are systematically absorbed by the human body about its intended purpose, the notified body will request a scientific opinion.

The Authority will issue an opinion within a maximum of 150 days.