Please Read Carefully: Label and IFU Revisions Take Effect Next Year
In the past two issues of this newsletter, we published a comprehensive glossary of revisions to Medical Device Directive 93/42/EEC and Active Implantables Medical Device Directive 90/385/EEC. Now, we begin another two-part article focusing on changes to labels and instructions for use (IFU) that will become law on March 21, 2010.
Manufacturers do not have to comply with the new requirements introduced by Directive 2007/47/EC until they become law. They may want to do so on a voluntary basis, however, and here’s why. The law contains no transitional provisions: medical devices placed on the market or put into service after March 21 must conform with the (new) requirements of the revised directives. This means that if the by-then noncompliant devices are still part of inventory at your manufacturing site, they cannot be shipped to the European Union. Devices received by European distributors before March 21, on the other hand, are considered to have been “placed on the market” and, therefore, can be sold to hospitals and users after March 2010.
Put simply, you would be well-advised to ship to your European distributor as much of your soon-to-be-noncompliant inventory as you can before the law goes into effect.
The two primary changes for labels and IFUs that will take place in March involve single-use devices (SUDs) and products containing phthalates. We will cover SUD-related revisions first, and address the phthalate issue in the November newsletter.
As noted in a previous article, the IFU for a device that has been classified as single use must include information about the known characteristics and technical factors that could pose a risk if the device were to be reused. For Class I and Class IIa devices, which do not require an IFU, the information must be made available to the user upon request.
We suggest that you add to the IFU one or more of the main reasons why your medical device is for single use or single patient use. For example:
- materials used in the manufacture of the device may not withstand repeated reprocessing and/or
- the design of the device may not facilitate cleaning and sterilization and/or
- the device may not perform as intended by the manufacturer if it is reused.
You should then describe the risks associated with the given reason(s). For example, reuse of the device may lead to:
- potential risk of cross infection/contamination associated with using inadequately cleaned and sterilized devices and/or
- failure of the device to perform as intended and/or
- material degradation and/or
- biocompatibility issues and/or
- endotoxinic reactions caused by reprocessing residues.
We also suggest adding a section in your risk analysis noting the solution to mitigate these risks is the single-use symbol on the product label and information in the IFU.
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.