What do CE numbers mean?

The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives.

What does CE marking mean?

The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.

What does CE 2797 mean?

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

Do CE marks expire?

How long is a CE certificate valid? Under the current system, CE certificates issued by Notified Bodies are generally valid for three years. The validity period may only be one year for some high risk devices. However, the status of your CE certification is dependent on maintaining your quality system certification.

Is CE certification accepted in UK?

The CE marking is only valid in Great Britain for areas where GB and EU rules remain the same. If the EU changes its rules and you CE mark your product on the basis of those new rules you will not be able to use the CE marking to sell in Great Britain, even before 31 December 2022.

What is CE certificate number?

The CE marking four-digit number that is displayed next to the CE mark on some medical devices is the Notified Body (NB) number. If there is no CE marking four-digit number, this means that the medical device is a Class I device that does not require NB involvement (i.e., self-declaration).

What does CE 0123 mean?

A CE marking followed by a four-digit identification number indicates that a Notified Body was involved in conformity assessment. CE 0123 shows that TÜV SÜD was the Notified Body involved in conformity assessment. Many consumers take the CE marking as a sign that a product is in conformity with the relevant directives.

Does UK accept CE mark?

Starting Jan. 1, 2023, the U.K. government will no longer recognize the CE marking for Great Britain market access. Products bearing both the CE marking and UKCA marking will be acceptable as long as they comply with the relevant U.K. rules.

What is the UK equivalent of the CE mark?

the UKCA mark
The government has announced a post-Brexit UK-specific equivalent to the CE mark, to be known as as the UKCA mark. The CE mark is applied to goods as a declaration that they meet the essential requirements of all relevant EU Directives.

What is CE marking and how do I get It?

CE marking is valid only for products for which EU specifications have been introduced. To affix the CE marking to your product, you must put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the product’s manufacturer, you bear sole responsibility for declaring conformity with all requirements.

When will the CE marking be accepted in Switzerland?

The CE marking will be accepted during a transition period that ends on 1-1-2023. b) Switzerland is not a member of the European Union, but for some products it accepts the CE marking as a presumption of conformity with Swiss national technical regulations.

What happens in the event of a challenge on CE marking?

In the event of a challenge, a report from a notified body may be submitted showing conformity of the equipment. This allows the manufacturer working with a notified body to show conformity with the safety objectives. See the entry on CE marking on the European Commission’s website.

Can I place a CE marking on a product outside the directive?

Before you place a CE marking on a product, you need to establish which EU New Approach Directives apply to your product. You must not attach a CE marking to a product outside the scope of the directives. The process you follow depends on the directives that apply to your product. 1.