EN ISO 14155:2003 is the European Standard dating from 2003 which governs Clinical Investigation of Medical Devices for Human Subjects. Manufacturers must use this standard to demonstrate compliance with EU requirements for clinical investigations detailed in the medical device directives. The International Organization for Standardization (ISO) is currently voting on the adoption of a revised version of the standard, which, if approved, will affect all medical device manufacturers. If adopted, the revised standard will become the standard of reference for conducting medical device clinical studies in the United States, Japan and other countries.
First and foremost, the revised standard will have a new title: “Clinical investigation of medical devices for human subjects — Good clinical practices.” It will also be available as a single document (the former standard was divided into two parts) and will be twice as long as the previous version. The document now includes nine clauses (instead of 15 in the previous version) and eight annexes instead of four in the 2003 version.
Worthy of note is also the fact that new requirements have been added to the standard: they deal for the most part with sponsor responsibilities, informed consent for vulnerable subjects, Ethics Committees, study monitoring, electronic data management and risk management. The revised standard stresses the fact that it applies to all clinical investigations and should be followed not only when clinical studies are needed to generate clinical study data, but also when studies are conducted for other reasons.
If adopted, medical device manufacturers should examine carefully the changes affecting ISO 14155 in the final standard, which will be harmonized in the EU. The expected revision of ISO 14155 will have a profound effect on the way medical device manufacturers will be conducting medical device studies worldwide and should not be ignored.
Mass communication is not as effective anymore. Advertising saturation and audience segmentation make it more and more difficult for companies and brands to reach their target consumers. Traditional marketing tools are confronted with new communication and information technologies that allow a two-way and interactive communication. Consumers are increasingly knowledgeable and demanding and skillfully control online media. The IMC (Integrated Marketing Communications) approach is born in this context in the attempt to find new ways of reaching out to target audiences.