July 28, 2021 | Series 1 / No. 8

Self-Declaration is a wonderful way for the regulators to make the businesses accountable and responsible for the products they are releasing in the market. It enables the regulatory authority to reduce the product regulatory costs by avoiding the issuance of certificates, while increasing the ease of doing business.

To provide the necessary scale, bring speed and simplicity to the regulatory approval process, reduce costs, and simplify the business process, the EU decided to limit its scope to publishing and managing the laws (called directives) and underlying technical standards. The certification process was delegated to the Original Equipment Manufacturer (OEM).

This was a productivity improvement measure, where the European Union (EU) showed the path to the rest of the world. Many countries are now adopting this method for conformity assessment.

Background:

To comply with the requirements in the European Union (EU), companies are responsible for issuing a Declaration of Conformity (DoC) to state that the product meets all the requirements of the applicable directives and underlying harmonized technical standards. Businesses are typically launching multiple new products in the EU every year. When existing products undergo major design changes, they may require revision of the DoCs. Moreover, directives and/or underlying technical standards are constantly changing, which may necessitate retesting of the product and revision of the existing DoCs.

Issues:

Following the footsteps of EU and more recently Australia, now several countries offer a DoC as a valid method of conformity assessment. Each one of them have their nuances, unique requirements and dependencies. Manual creation and maintenance of the self-declarations for different products and markets takes significant time and efforts.

Below are references of some markets offering Self-Declaration:

• European Union:
  Today, in order to create a DoC, the compliance engineers manually create the document, outline the products affected, select the applicable directives and underlying standards that have been used to demonstrate the presumption of conformity, seek an approval from management, print the DoC documents, obtain signatures of the company authority, finally archive an electronic copy as well as make hard copies so that the DoC can be distributed with respective products being shipped to the EU!
  
  As an OEM, you may choose the language in which you want to publish the DoC. The EU Declaration of Conformity must be drawn up in one of the 24 official languages of the European Union. The EU Member States or the market surveillance authorities may require that the DoC is translated into a local language or languages. This requires the OEMs to have the translation services to ensure the correct translation in each of the languages. Manually creating a DoC for multiple languages, maintaining it, and making available to the stakeholders requires sizeable efforts. Lastly, for the imported products, the importer must keep a copy of the DoC for 10 years after the product has been placed on the market.

  

  The manual process of creating, reviewing, approving, signing and sharing a DoC is repetitive in nature and requires collaboration among multiple stakeholders. Additionally, keeping track of changes in EU directives and underlying standards so that the latest and applicable directives and standards are used for the presumption of conformity, identifying the impacted products and DoCs due to these changes in directives and standards, and updating the DoCs to reflect the correct standards consume important time of valuable resources.

• United Kingdom:
  On January 1st, 2022, businesses shipping products to the UK will be required to provide the self-declarations fulfilling the UKCA (United Kingdom Conformity Assessment) requirements and marking. Assuming that all products being shipped to the EU today are also now shipped to the UK, one of the biggest markets in Europe, the Compliance team will be tasked with creating an additional DoC for the UK for every DoC it already has in place for the EU! This is a serious task for a compliance team of a mid-size company as it may end up becoming a sizable work.

• Australia & New Zealand
  These markets are closely aligned with the product regulatory compliance processes of the EU. The self-declaration is called Supplier’s Declaration of Conformity (SDoC). The OEM or a third-party on behalf of the OEM must register in the national database as a responsible supplier. The resulting information must be included in the DoC.

• USA and Canada
  Today, in Canada and the USA, the technical requirements for the product regulatory approval process are harmonized to minimize a manufacturer’s burden. Beginning in 2018, the FCC made major changes in the approvals process. At this time, FCC introduced the concept of the SDoC as a simplification and unification of the regulatory approval process for various kinds of equipment. A significant portion of the changes in 2018 expanded on the concept of ‘responsible party’, and now requires the SDoC and user documentation to include contact information for the responsible party that must be resident in the USA.

• Taiwan
  Taiwanese DoC requires self-declaration in Chinese (Traditional) conformance to the Bureau of Standards, Metrology and Inspection (BSMI) standards. Along with Chinese (Traditional), it allows English language on the DoC. Moreover, the test lab has to be approved by BSMI, and this information must be included in the DoC. Lastly, the DoC must also bear the stamp (seal) of the responsible party resident in Taiwan.

• Morocco
  Morocco recently implemented a DoC process, which requires the DoC be published either in French or Arabic! In conjunction with this process, Morocco also added a requirement for a compliance mark, which becomes mandatory in late 2021.
  
  Many other countries such as, but not limited to, Kazakhstan, Ukraine, Barbados, etc. require a self-declaration as part of the product regulatory compliance process.

Needs:

More and more countries are adopting DoC as a valid method of conformity assessment. The requirements, formats and languages of the DoC may vary from country to country. Therefore, a solution with a rule-based engine that facilitates automation in creation and maintenance of these country-specific DoCs (in the mandated language) is the need of the hour.

The solution should offer a workflow promoting the automation of the DoC generation process that includes creation, review, approval, digital signature, search and share. Additionally, the solution should promote a close collaboration with key stakeholders including, but not limited to, the Compliance professional, Compliance Manager, company authority responsible to authorize (sign), and Test Lab(s) responsible for providing the test reports as the supporting evidence to the DoC. Moreover, the solution should provision for associating the supporting records with the DoC so that it is easy to trace the evidence of product regulatory compliance in the future.

Lastly, continuous monitoring of the changing laws and underlying standards is a must so that the business can create a technically proper DoC, and can modify the existing DoCs if there is a change in the requirements.