Everything you need to know about obtaining the CE Marking and bringing your products to the EU market
What is CE Marking?
The CE marking proves that goods meet the applicable EU regulatory requirements. CE is an abbreviation of the French “Conformité Européenne”, which means “European Conformity”. Countries within the European Economic Area (EEA) or European Free Trade Association (EFTA) will require the CE Marking symbol if the EU legislation foresees it for that product.
The CE Marking is a conformity marking used for several legislations covering numerous products and product types.
What products need the CE Marking?
To be sold in the EU, EEA, and EFTA areas, the following products must bear the CE Marking:
- Medical devices and in vitro diagnostic medical devices
- Construction products
- Machinery equipment
- Electronics, including radio and telecommunication equipment
- Personal protective equipment
- Pressure equipment
- Others: equipment and protective systems for use in explosive atmospheres, simple pressure vessels, gas appliances, lifts, cableways, explosives for civil use, new hot water boilers, measuring equipment, non-automatic weighing instruments, and recreational craft.
For certain types of products, such as electrical and electronic equipment, RoHS Directive, which is a CE marking Directive also applies to restrict the use of hazardous substances to protect the environment.
When is CE marking not required?
While the CE Marking is a crucial compliance marking for many products sold in the EU, EEA, EFTA, it cannot be used for certain products. Cosmetics, foodstuffs, chemicals, pharmaceuticals, and products covered by the GPSD cannot bear the CE Marking. Additionally, for marine equipment, the wheel mark is required.
What manufacturers need to do to obtain the CE Marking?
Manufacturers need to obtain the CE Marking to sell their products legally in the EU, EEA, EFTA. Once the product complies with the health and safety requirements laid down by the applicable legislation (normally presented in Annex I of the legislation), the manufacturer must affix the CE marking on the product. As part of the compliance process, some products will require a third-party conformity assessment by a notified body. In contrast, for some others, the manufacturer can apply harmonised standards or self-declare the conformity of that product.
It is important to note that CE Marking is still recognized in the UK market as well, making it an even more valuable marking to have. After the transitional period will end in the UK, manufacturers will need to apply the UKCA marking!
No matter the marking of the designated market – manufacturers not established in those markets will also need to designate an Authorised Representative or Responsible Person to sell in the EU, UK, or Switzerland.
Obelis Solutions for CE Marking Compliance
Obelis Group can ensure your product meets the necessary requirements to affix the CE Marking to gain market access. By appointing Obelis as your regulatory partner,
- We will guide you through the compliance process, reviewing your documentation and updating you on regulatory changes.
- We can help you locate a Notified Body for third-party conformity assessments, which are mandatory for certain products. And if you are looking to access other world markets on behalf of the manufacturer for Free Sales Certificates (FSC)
- We will take on the role of your in-country representative
- We offer a full range of regulatory services for manufacturers to help you navigate the complex regulatory
- compliance domain.
Are you a non-EU/UK/CH manufacturer looking to bring your products to the European market?
We offer in-country representation in several markets! We will act as your authorized representative or responsible person, which is a mandatory requirement for non-EU/UK/CH manufacturers under certain legislation.
Want to learn more about CE Marking requirements and how to navigate the certification process for successful product sales?