Identification of Standards and Trends
The market for medical devices and the associated services is a market with short innovation cycles and is therefore associated with many challenges and changes. In particular, the regulatory and normative requirements for medical devices and their conformity assessment are subject to constant innovations or changes. The early identification and consideration of these new or changed requirements is a decisive prerequisite for a successful and effective conformity assessment procedure and the maintenance of the valid status of a medical device on the market.

It is of immense importance for the user of standards to ideally participate actively in standardization work or at least to be provided with this information promptly. Especially for development projects, the early identification of normative trends such as cybersecurity, artificial intelligence (AI) or big data is of decisive importance.

Tasks of the DIN Medical Standards Committee (NAMed)
The medical device industry has a strong international orientation, which means that European and international standardization is of great importance for NAMed. Companies operating worldwide rely on standards for access to markets. The mirror committees of NAMed determine the national positions on European and international standardization projects and send experts to the corresponding committees. In addition, German experts become involved by assuming key functions in European and international bodies, such as chairing a technical committee.

Safe, state-of-the-art medical devices – this is what the DIN Medical Standards Committee (NAMed) has around 500 experts working for in its specialist committees. The main players are manufacturers of medical devices, representatives of testing and certification institutes, physicians, representatives from research and development and the public sector. NAMed is responsible for national standardization and represents German standardization interests at European (CEN) and international (ISO and IEC) level, including in the field of medical devices. NAMed develops standards in the aforementioned areas with the aim of establishing the highest possible level of quality for standardized products and procedures, thus making a decisive contribution to patient safety.

European standards (EN) must be announced at national level in all CEN member countries and published or recognized as identical national standards (e.g. DIN EN). Conflicting national standards must be withdrawn. The national adoption of an international standard (ISO) is voluntary. Adoption is usually decided by the national working committee (DIN ISO). An international standard (ISO) can be adopted by CEN as an EN-ISO standard and consequently also as a DIN-EN-ISO standard at national level.

NSF International (former PROSYSTEM) is an active member of many of these working groups and provides its experts on a variety of topics. Through our involvement in DIN and our secondment to European and international commit-tees (ISO/IEC), we can exert influence on the results of standardization at an early stage.

Process for Identifying Standards and Trends
Many manufacturers lack a procedure for identifying new or changed normative requirements and their trends. Unfortunately, it is not enough to check the relevant internet pages from time to time to see whether there are new or changed standards, since the results and trends are usually only communicated to the outside world at the end of a project. It is therefore important to have at least one “informant” in the standardization groups that are important for the organization in order to obtain the necessary information as early as possible and to be able to exert influence or take countermeasures if necessary.

Our active cooperation in the creation of standards offers our customers a wide range of advantages:

Strategic marketing: The opportunity to successfully place technologies and products on the market at an early stage.

Competitive advantage: Direct influence on the content of standards at national, European and international level.

Knowledge advantage: Early recognition of development trends and market opportunities and thus risk reduction in research and development activities.

Knowledge transfer: Structured exchange of knowledge between manufacturers, users or regulators, since all interested parties are involved in the development of a standard.

NSF International informs its customers immediately about new normative requirements or trends and helps them to identify valid data sources for the evaluation of their processes and medical devices.