About CE Marking
CE Marking (Conformité Européenne) is the mandatory product certification mark for products sold within the European Economic Area (EEA). It signifies that a product meets EU safety, health, and environmental protection requirements across applicable directives and regulations. Without CE Marking, most manufactured products cannot legally be sold in the EU market — making it essential for Asian exporters targeting European buyers, distributors, and retailers.
Our CE Marking Services
- Medical devices (MDR 2017/745 and IVDR 2017/746)
- Electrical and electronic equipment (LVD, RED, EMC directives)
- Machinery (Machinery Directive 2006/42/EC)
- Toys (Toy Safety Directive 2009/48/EC)
- Personal protective equipment (PPE Regulation 2016/425)
- Construction products (Construction Products Regulation)
- Pressure equipment (PED 2014/68/EU)
- Measuring instruments and non-automatic weighing instruments
Why Work With ISOAsia?
ISOAsia has guided hundreds of Asian businesses through CE Marking and related compliance programmes. Our consultants combine deep regulatory knowledge with practical implementation experience — ensuring your certification project is completed efficiently, correctly, and to the highest standard.
Free Initial Consultation: Not sure if CE Marking is right for your product or business? WhatsApp our specialists for a free, no-obligation assessment of your requirements.
Frequently Asked Questions
Most products sold in the EU market require CE Marking, including electrical and electronic equipment, machinery, medical devices, toys, PPE, construction products, and many more categories.
Some product categories require independent assessment by an EU Notified Body. Others can be self-declared by the manufacturer. ISOAsia advises on the correct conformity assessment route for your specific product and directive.
ISO 13485 is not strictly mandatory but is strongly recommended for medical devices CE Marking — particularly for Class II and III devices where a Notified Body is required. Most Notified Bodies strongly prefer or require it.