What is CE ?
- shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
- is an indicator of a product’s compliance with EU legislation
allows the free movement of products within the European market.
According to Medical Device Regulation 2017/745 , the EU manufacturer can apply directly to the local government agency (Competent Authority). If the medical device is manufactured outside of EU, the EU Authorized Representative assists the manufacturer to apply.
Application for CE Mark registration process
- Determine the directives and harmonized standards and other requirements that the product complies with
- Determine whether product classification requires third-party notified body to participate in verification
- Prepare Technical files required by the preliminary directive
- Contact European Union Authorised Representative to register the local medical equipment government department
- Affix the CE mark & EU Authorized Representative information on your product and make an EC Declaration of conformity.
To discuss how our team can help your company achieve CE MARK, please
Tel : +44 (0) 2034 888 333
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Frequent Asked Question
It depends on the categories of product and product complexity.
It depend on the product category and product complexity, availability of testing report, production control and ISO Certification.
Absolutely Yes. In general, ISO Consultant will help technical files and liaise with EU Representative guide your company to prepare until getting CE Mark.
In general, the company can put the CE Mark on the packing & product after completion of CE registration .
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Over 20 Years in ISO Certification Consultancy industry and completion over 400+ Projects.
Over 10 years of experiences in the fields of Quality Management, Environmental Management, Safety Management, Business Continuity Management and Information Security Management.