Easy Medical Device is your one stop shop for Quality and Regulatory Affairs regarding Medical Devices.
We support customers on their journey to become compliant to the regulatory requirements and one of them is to have an EU authorised representative if they are not located in Europe.
We are already offering the service of Swiss Representative and UK Representative. Now we have added the EU Representative service to be able to support you on all aspect of your strategy.
Monir El Azzouzi CEO of Easy Medical Device will be your Person Responsible for Regulatory compliance.
Role & responsibility of the European Authorized Representative
Below is the list of activities that Easy Medical Device will perform so you remain compliant with the European Legislation.
- verify that the EU declaration of conformity and technical documentation has 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, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
- comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
- 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, in an official Union language determined by the Member State concerned;
- 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;
- terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
Blog post
If you want to learn more about the role and responsibility of an EU Authorised Representative, you can check the below blog post.
Contact us
For any questions related to our services, please don’t hesitate to contact us. Below are the details.
Address: Guldenberg 1 box 2-4 – 2000 Anvers – Belgium
email: eurep@easymedicaldevice.com
Phone: +32 484 39 01 11
Telephone No.+3232315556