Question 1

What is CE Marking?

Accepted Answer

CE marking is a prerequisite for placing on the market and allowing the free circulation of certain products, constituting a guarantee from the manufacturer that these products comply with the general safety and performance requirements applicable to them.

Question 2

Does CE Marking apply to all products?

Accepted Answer

No. CE marking is only mandatory for products covered by EU specifications that require the affixing of the CE Mark. It is prohibited to affix the CE marking to products for which there are no EU specifications or for which existing EU specifications do not require the affixing of the CE Mark.

Question 3

Does the CE mark have defined graphics?

Accepted Answer

Yes. The CE mark consists of the letters “CE”, it cannot be smaller than 5 mm and the two letters must be the same size. The graphics of the letters must comply with the requirements set out in the EU documents.

Question 4

What is the validity of the CE Marking?

Accepted Answer

The CE Marking has no defined validity period.

Question 5

In which countries is CE Marking mandatory?

Accepted Answer

The CE Mark is mandatory for products that are to be placed on the market in the European Economic Area (EEA), allowing the free movement of products in these countries.

Question 6

Do I need to appoint an Agent to place my products in the EEA?

Accepted Answer

Only non-European manufacturers who intend to place their products in the EEA need to appoint an Authorized Representative.

FAQs

What is CE Marking?

Does CE Marking apply to all products?

Does the CE mark have defined graphics?

What is the validity of the CE Marking?

In which countries is CE Marking mandatory?

Do I need to appoint an Agent to place my products in the EEA?

Useful links

EU - European Union

IPIUE - Instituto Da Propriedade Intelectual Da União Europeia

INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.

EUDAMED - Base de dados europeia sobre dispositivos médicos

ISO – International Organization For Standardization

ECHA – Agência Europeia de Substâncias Químicas

CEN- European Committee For Standardization

CENELEC – European Committee For Electrotechnical Standardization

Base de Dados NANDO – Organismos Notificados

Marcação CE