With the release of European MEDDEV 2.14/3 REV 1 in 2007, the European Commission now allows In-Vitro Diagnostics (IVD) companies with products intended for PROFESSIONAL USE ONLY to place Instructions for Use online instead of including a printed booklet inside the product packaging. Further, the release of Regulation 207/2012 in March 2013 modified the Medical Devices Directive 93/42/EEC (MDD), allowing for the possibility of leveraging electronic Instructions for Use for certain types of Medical Devices.
Since Europe has more than 20 official languages, this can be an advantage for medical device and IVD companies and ultimately results in an enhanced end user experience.
Give customers online access to Instructions for Use (IFU) while meeting all European regulations.
Emergo, in partnership with Qarad of Belgium, now offers an online system that allows your professional use customers to have instant online access to your Instructions for Use. The system utilizes unique Key Codes, a dedicated website address and European-wide toll-free telephone numbers printed on your product labeling.
Call centers accessible from all European countries also allow users to request printed IFUs.
A key requirement of European MEDDEV 2.14/3 REV 1 for In Vitro Diagnostics Devices, and Regulation 207/2012 for Medical Devices is the need to provide a toll-free phone number users can call to order a printed IFU in EVERY country where your product is sold. However, this is very difficult and expensive for companies to set up. As part of this service, your end users will be able to call our established network of toll-free call centers in most European countries staffed by people ready to handle your end user requests in their native language.
Enjoy the advantages of medical device and IVD e-labeling: having your IFU documents online.
- Lower Costs: Printing IFU booklets is expensive if you add the cost of printing and adding inserts to every package. Printed documents must also be shipped along with the products, increasing costs for storage and shipping.
- Faster IFU Changes: Changes to your Instructions for Use (IFU) can be made quickly and uploaded to replace the old version, while preserving the old version until the expiration of the corresponding product lot. The system maintains full revision control and users always get the correct IFU version because a unique Key Code is printed on the package and linked to the appropriate IFU on our website.
- Less Risk: Large combined booklets with many languages are daunting for users to read. The sheer volume of text discourages them from reading it. Creating separate smaller IFU documents for every language instead of having one large document with multiple languages is more user friendly and lessens risk to your company, users and patients. Having a single online document in their native language greatly improves the likelihood that users will read the IFU.
- Environmentally Friendly: Most companies combine languages into a single IFU document. This wastes untold tons of paper each year that could be avoided. Having documents online is much more ecologically friendly.
Medical device and IVD e-labeling pricing based on number of documents you maintain online.
Our system provides secure, online access for your regulatory department and allows users to upload and replace documents in a revision controlled environment. Fees for the service are simply based on the number of documents stored in the system, not on size or usage. This makes it very easy for you to determine how much the service will cost and compare this to how much you are currently spending to send printed IFUs in your products distributed within Europe.
Contact us today for more information on our IVD and medical device elabeling service.