October 19, 2021 | Series 1 / No. 11

The product regulators of different countries and markets make the regulations, which are laws. But it is the underlying technical standards that give the form and shape to these laws and clarify the requirements as they relate to the product being approved and launched in a market.

The regulatory approval (certificate or self-declaration) needs to show the exact, applicable standards the product is tested for, with the accepted version of each standard. It is imperative that the businesses learn in advance about the upcoming changes in the standards so that they can design and test their products for appropriate standards and be ready with the relevant required approvals.

Background:

Businesses are required to ship their products that meet the current standards accepted by the regulators. Failure to demonstrate the presumption of conformity to the accepted standards results into non-conformance of the product, creating a negative impact on the business.

Reasons for the continuous changes in the technical standards:

Following are some of the reasons for the continuous changes in the technical requirements:

1. For the purpose of harmonization and standardization, global Standards Development Organizations (SDOs) are harmonizing the regional and local standards. The event of global standards replacing the local standard has accelerated many changes.
   
   
   1. Example: Earlier, the leading European countries would publish their own, country-specific technical standards. For instance, Germany, UK, France, Italy etc. would each publish its own regulatory requirements. In that era, getting a European approval would require working with authorities in each of the countries, which consumed huge efforts and time, and was very expensive. Today, CENELEC, CEN, ETSI are the three European Standards Organization (ESO), whose standards are harmonised and recognized as European Standards (ENs). At a regional level, for Europe, these are the accepted standards in support of the European regulations.
      
      
   2. Example: Earlier, Russia published its own set of GOST standards. In the Post-Cold War era, the Eurasian Economic Union (EAEU) comprised of five countries - The Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic and the Russian Federation – is working towards the harmonization of the technical requirements. The Technical Regulations (TR) formed by the Eurasian Economic Commission (EEC) allow harmonization of pan-EAEU requirements.
      
      
   3. Example: Gulf Standardization Organization (GSO) is the SDO for Gulf Cooperation Council (GCC), comprised of six countries – Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and United Arab Emirates. The GSO develops the standards, and when accepted, become the national standard for each of the member states. 
      
      
2. More countries are finding out product regulatory compliance as a way to address their country-specific requirements as well as incremental means to generate revenue. Even though the smaller markets or countries are aligned with the international harmonized standards, their respective national regulators first adopt the global standards at the national level before implementing them. This results into differences in the standard name, version and the acceptance date than the international standard used as the basis.
   
   
1. Example: International Electrotechnical Commission (IEC), an international organization, has published the latest product safety standard IEC 62368-1; the latest version currently stands at IEC 62368-1:2018/COR1:2020. However, today, as of the publication of this editorial, the EU’s list of harmonised standards accepts EN 62368-1:2014 AND EN 62368-1:2014/AC:2015 as the valid versions that can officially be used to demonstrate a presumption of conformity. 
   
   
2. Example: In the above example, IEC has published a newer standard (IEC 62368-1) intended to replace the current standard (IEC 60950-1 & IEC 60065). Many countries have adopted and nationalized this standard. However, some countries, such as Mexico, are still aligned with the previous standards – see the illustration above.
   
   
3. The fast-advancing technologies are a catalyst to the continuous changes in the technical standards. In response to the changing technologies, the global SDOs keep making changes to the existing standards to incorporate the new technologies.
   
   
1. Example: It has been recognized that technology-based standards will continuously need updates to address the new technologies that are introduced.  To help eliminate this continuously changing technical requirements, the latest product safety standard IEC 62368-1 has adopted a new philosophy in that the standard seeks to identify the hazards that can exist and then reviews the means that have been implemented to prevent the particular hazard from occurring.  This is then repeated for all conceivable hazards that might exist. This way the standard is technology independent and will not require revisions to address new technologies in the future.
   
   
2. Example: As Cellular telecommunications technologies advanced from 2G to 3G to 4G, and now to 5G, the underlying technical performance standards had to be modified to stipulate the characteristics of the newer technologies.

Issues:

The landscape of the product regulatory standards is continuously evolving and therefore dynamic in nature. If a product is affected by the change in a standard, it needs to be retested so that it can maintain the valid approval. Sometimes, having this information and intelligence about the impending future changes can be used by the company in designing and testing the product to the upcoming standard (before even it is released) so that the product does not have to undergo additional round of testing in the future (while it is already released and being marketed), thus avoiding additional costs and time of the resources.

Obtaining timely information of the upcoming changes in the standards and their direct impact on the products is a challenge. There are service providers who serve the market by providing the reports of changing standards. However, the information of the changing standard does not identify the impacted documents and products. From receiving a generic report, the businesses have to narrow down on the changing standards that are applicable to their products, which is time consuming.

Needs:

The businesses would like to receive intelligence about the changing or new standards that are used in demonstrating the presumption of conformity by their products.

The information should be concise; it should possibly include a summary of the new or revised standard, the effectivity date by which the products need to conform to the new standard, whether the changes impact only the new products or the products that are also in the production etc.

Importantly, the changing standard should also identify the impacted products (SKUs) and records (file names)! That is a real value add!

Lastly, an automated, closed-loop decision-making process is desirable that allows routing of the impacted records for a review of the stakeholders so that a decision could be made if the business would like to spend resources for retesting the impacted products to the new standards. Sometimes, the business determines not to retest a product that is nearing end of life (EOL).