On May 26th 2021 the Medical Device Regulation (MDR) became the only regulation applied to medical device manufacturers throughout Europe; major changes and new requirements were introduced.
the Swiss Federal Government has decided to terminate negotiations on the EU-Swiss Institutional Framework Agreement. As a direct consequence, the Mutual Recognition Agreement is not being updated, forcing Swiss companies to act as if from a third country and establish European Representatives in order to access the European market.
One of the requirements is to appoint a Swiss Authorised Representative for your company. Easy Medical Device GmbH can help you with that.
Or book your meeting now to discuss about your project.
Monir El Azzouzi CEO of Easy Medical Device GmbH will be your Person Responsible for Regulatory compliance.
Role and responsibility of the Swiss Rep
Below is the list of activities that Easy Medical Device GmbH will perform so you remain compliant with the Swiss Legislation.
- Ensure that the declaration of conformity and technical documentation have been drawn up, verified and checked; and, where applicable, that an appropriate conformity assessment procedure has been carried out by Manufacturer.
- In response to a request from the Swissmedic, support the Swissmedic with all the information and documentation necessary to demonstrate the conformity of a device.
- Cooperate with the Swissmedic on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Keep available a copy of the technical documentation or ask the manufacturer to keep it available for the authorities (Direct contact with them), a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the Swissmedic.
- Forward to Manufacturer any request by the Swissmedic for samples, or access to a device, and ensure that the Swissmedic receives the samples or has been given access to the device.
- Immediately inform Manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- If the manufacturer acts contrary to its obligations under these Regulations:
- Terminate the legal relationship with the manufacturer; and
- Inform the Swissmedic and, if applicable, the relevant approved body of that termination.
- Any change of Swiss Authorized Representative is done following EU MDR 2017/745 article 12
For any questions related to our services, please don’t hesitate to contact us. Below are the details.
Address: Bernoullistrasse 20, 4056 Basel
Phone: +41 79 90 36 836