This is the second of a two-part article on changes to labels and instructions for use (IFU) in Directive 2007/47/EC, which will become law on March 21, 2010. In part 1 of the article, published in the September issue of the Consultants Corner newsletter, we discussed the effect of this directive on IFUs for single-use devices. This time we will focus on how devices containing phthalates will be affected.
The directive’s Essential Requirements (Annex 1, Section 7.5) states that medical devices containing certain phthalates that are intended to administer and/or remove medicines, body fluids or other substances to or from the body or devices intended for transport and storage of such body fluids or substances shall be appropriately labeled.
The European Commission has mandated CEN to produce a standard (prEN 15986) that specifies the technical requirements and a suitable label. In the meantime, here are some recommendations regarding the use of IFU and phthalate symbols on the label.
If the aforementioned device may be used by children and pregnant or nursing mothers, the IFU shall provide information on residual risks affecting these patient groups and, if applicable, appropriate precautionary measures. Even if the medical devices are excluded from EC regulation N°1272/2008 on the classification, labeling, and packaging of substances and mixtures consulting the regulation is worth the effort as you may find information that can be used in an IFU. For example, the phthalate BBP (benzyl butyl phthalate) is classified as:
- Toxic for reproduction, Category 2 R61. The associated phrase for R61 is: May cause harm to the unborn child.
- Toxic for reproduction Category 3 R62: Possible risk of impaired fertility.
The chemical risk and safety phrases are translated into 23 European languages at the Europa website.
Symbols should be placed on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. Eucomed has issued a recommendation on symbols (shown below) that should be used. However, the final standard may differ from what is shown here. Until the relevant EN standard is published and harmonized, an explanation of the symbol must be included in the IFU.
The symbol and proposed qualifier consists of the generic “contains PHT” symbol accompanied by the name of the phthalate classified as CMR 1 or 2. The phthalate’s name shall be positioned adjacent to the generic symbol. The examples below are for illustration only and do not represent the only ways to achieve compliance with the forthcoming standard.
This symbol indicates that the material used for the manufacture of this specific medical device contains DEHP:
This symbol indicates that the material used for the manufacture of this specific type of medical device contains DBP:
This symbol indicates that the material used for the manufacture of this specific type of medical device contains BBP:
This symbol indicates that the material used for the manufacture of this specific type of medical device contains several phthalates (DEHP and/or DBP and/or BBP):
Just as a reminder, the final standard might be different from what is described in this article. The Consultants Corner newsletter and MediMark Europe cannot guarantee the accuracy, adequacy or completeness of any information contained in this document, and cannot be held responsible for any errors or omissions.
René Clément is co-chairman of MediMark Europe, which serves as an authorized representative for US manufacturers of medical devices and IVD products. For more information about the firm, visit the company’s listing in the online Consultants Directory, or go to www.medimark-europe.com.