Conformity Assessment Procedure
What is a Conformity Assessment Procedure?
A conformity assessment procedure is the process by which a manufacturer demonstrates that a product meets the applicable regulatory requirements before placing it on the market. Under EU and UK product legislation, conformity assessment is a mandatory step in achieving CE marking, UKCA marking, or CE UKNI marking, and the specific procedure required depends on the product category, its risk classification, and the applicable legislation.
Why It Matters
Conformity assessment is the mechanism through which regulatory requirements are translated into verified compliance. It is not sufficient for a manufacturer to believe their product is safe and compliant — they must be able to demonstrate this through a defined process that may involve internal assessment, third-party testing, quality management system audits, or independent certification by a Notified Body or Approved Body.
Choosing the correct conformity assessment route is a critical decision. Using an inappropriate procedure, or failing to involve a Notified or Approved Body where required, renders any marking applied to the product invalid and the product non-compliant — regardless of its actual safety performance.
For manufacturers across all regulated product categories, understanding which conformity assessment procedure applies to their product is an essential first step in achieving lawful market access.
Key Requirements
What Determines the Conformity Assessment Procedure?
The applicable conformity assessment procedure is determined by:
- The product category and the EU or UK legislation that governs it
- The risk classification of the product within that legislative framework
- Whether third-party involvement from a Notified Body or Approved Body is required
This requirement applies across multiple regulatory frameworks covering product categories including:
- General product safety
- Electrical and electronic equipment
- Machinery and industrial equipment
- Personal protective equipment
- Toys and children’s products
- Medical devices and in vitro diagnostics
For lower-risk products, manufacturers may be able to self-certify conformity through an internal production control procedure. For higher-risk products, involvement of a Notified Body or Approved Body is mandatory.
Responsibilities Relating to Conformity Assessment
While specific obligations depend on the product category and applicable legislation, responsibilities commonly include:
- Identifying the correct conformity assessment procedure for the product and its risk classification
- Compiling technical documentation demonstrating how the product meets applicable requirements
- Engaging a Notified Body or Approved Body where third-party assessment is required
- Completing all required assessment activities before affixing the applicable conformity mark
- Drawing up a Declaration of Conformity upon successful completion of the procedure
- Maintaining records of the conformity assessment and keeping technical documentation up to date
Conformity Assessment and the Authorised Representative
For non-EU manufacturers, the conformity assessment procedure must be completed before CE marking can be applied and before the product is placed on the EU market. The EU Authorised Representative plays an important role in this process — holding or providing access to technical documentation and acting as the point of contact for competent authorities who may wish to verify the conformity assessment carried out.
For the Great Britain market, the UK Responsible Person fulfils an equivalent role in relation to UKCA marking and the UK conformity assessment framework.
Need GPSR compliance support?
Euverify provides EU Authorised Representative services for manufacturers and ecommerce sellers placing products on the EU market. Our team supports documentation review, regulatory communication, and ongoing compliance management.
Further Reading
