Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Taking advantage of elabeling for IVD companies

In 2007 the European Commission released MEDDEV 2.14/3 REV 1 which opened the door for IVD companies with professional use products to place their Instructions for Use (IFU) online instead of placing multilingual paper inserts inside product packaging. That could be a huge cost savings to some IVD companies but one key requirement makes it difficult for IVD companies to take advantage of elabeling. The MEDDEV stipulates that companies must provide a toll-free number in every European country where the product is sold. That's a big challenge since there is no real pan-European toll-free phone number. However, we thought that you might be interested in knowing that one of our partners offers a reasonably priced elabeling service for IVD companies.