A new regulation for medical devices on the use of electronic instructions for use (IFU), or e-labeling, has been approved by the EU Council and European Parliament.
The new regulation will not require transposition into the laws of individual countries. This means manufacturers will have the option to implement e-labeling from March 2013 onwards.
Scope of the proposed new regulation
E-labeling will only be for devices exclusively used by professional users (home use devices will not be covered) and applicable to Medical Devices Directive 93/42/EEC (as amended by 2007/47/EC) and Active Implantable Medical Devices Directive 90/385/EEC.
Article 3 of the proposed new regulation defines the medical devices eligible for e-labeling, including:
- Standalone software (93/42/EEC)
- Medical devices and their accessories with a built-in system virtually displaying IFUs (93/42/EEC)
- Fixed installed medical devices (93/42/EEC)
- Implanted medical devices and their accessories (93/42/EEC)
- Active implantable devices (90/385/EEC)
(NB: A full review by manufacturers of Article 3 is recommended, as caveats to the above designations are included.)
The use and provision of e-labeling will remain at the discretion of the manufacturer and will not be mandatory for all medical devices.
Should a manufacturer decide to implement e-labeling, the completion of a documented risk assessment will be mandatory. Article 4 of the proposed new regulation identifies the specific requirements for the risk assessment. An important point of note is the need for the risk assessment to demonstrate that an e-label maintains or improves the level of safety attained by an equivalent IFU in paper format.
Availability of IFU in electronic format
Unless the risk assessment demonstrates clear justification for its omission, the electronic IFU will need to be available in all EU countries where the product is sold. In addition, the manufacturer will have to set up a website for access to the electronic IFU and have a system in place for the provision of the IFU in paper format. The paper IFU will have to be delivered within seven days of request and at no added cost to the user.
Article 5 of the proposed new regulation describes further requirements placed on the manufacturer if they wish to use e-labeling.
During the annual regulatory audit, as part of the normal conformity assessment process, a manufacturer that chooses to use e-labeling (in accordance with the proposed new regulation) will have their implementation processes reviewed by the Notified Body.
SGS will not require notification in advance of any decision to use e-labeling.