As a member of ISO and IEC, I often encounter questions about the differences between an International Standard (IS), Technical Report (TR), Technical Specification (TS), and European Standard (EN). Understanding the difference between these types of documents and their compliance levels is crucial for medical device manufacturers and often misunderstood, both by newcomers to the industry, as well as seasoned regulatory affairs professionals. Here’s a quick guide:
 
🔹 Technical Report (TR)
TR documents, such as ISO/TR 24971, provide guidance and information rather than mandatory requirements. They are designed to support manufacturers in understanding and implementing best practices related to, for example, risk management, usability engineering, and other aspects of medical device development. While not compulsory, adhering to the recommendations in a TR can enhance the robustness of a manufacturer’s processes and align them with industry expectations, potentially facilitating regulatory approval.
 
🔹 Technical Specification (TS)
A TS provides requirements and recommendations based on the latest technical advancements and market needs. It’s a more flexible document compared to an IS and can be used when there is a need for a fast-track solution or when the subject matter is still under development. TS serves as a stepping stone towards a full International Standard, allowing industry feedback and refinement.
 
🔹 International Standard (IS)
IS documents, such as ISO 13485 for quality management systems in the medical device industry, are formal requirements that must be implemented to achieve compliance. These standards are often mandated by regulatory bodies and need to be integrated into a company’s Quality Management System (QMS) and product development processes. Compliance with these standards ensures that products meet safety, efficacy, and regulatory requirements.
 
🔹 European Standard (EN)
An EN is a standard developed by CEN (European Committee for Standardization) or CENELEC (European Committee for Electrotechnical Standardization) that applies across Europe. While not inherently legally mandatory, EN standards often become de facto mandatory when referenced by European regulations or directives, facilitating trade and ensuring safety and interoperability within the European Single Market.
 
📊 Being a visual learner but terrible at drawing, I tried to depict this relationship in the diagram provided above.
 
📚 Sources:

ISO Standards
IEC Standards
EN Standards