CE marking
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
Products we service
- Medical devices MDR
- In Vitro Diagnostic Medical Device IVDR
How to supply Medical Device in EU?
The medical devices must get a CE certificate and apply the CE marking to the product itself or to the packaging before place into the market, except Class I medical device and Class A In vitro Diagnostic Medical device, the manufacturer of Class I medical device and Class A In vitro Diagnostic Medical device shall draw up and sign the EU Declaration of Conformity, and affix CE marking to the product itself or to the packaging.
If the manufacturer is not located in EU, the manufacturer must appoint an Authorized Representative in EU.
KINGSMEAD SERVICE BV can act as your EU Authorized Representative for you, please feel free to contact us for the details.
Responsibilities of EU Authorized Representative
The main responsibilities include:
- verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
- keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate;
- in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device;
- forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
- cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
- immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
For the details, please refer to Article 11 of MDR and IVDR
