Manufacturers that want to sell devices in the EU, UK and Swiss region need to follow the legislation linked to their products.
- For Europe this is MDR 2017/745 and/or IVDR 2017/746
- For Switzerland this is MedDo and IvdDo
- For UK this is for the moment the UK MDR 2002 but this will change soon.
If you are located in a foreign country and want to market your products in EU, UK or Switzerland, you need to have a Representative Company in the region.
Example: If you are a US company and want to sell your products in France, then you need to appoint an EU Authorized Representative and an Importer for all the European Union.
In the case you want also to market your products in the UK or in Switzerland, you need to appoint additional representatives and importers in each of those countries.
Another case is if you are located in the European Union, your company doesn’t need an EU Authorized Representative. But to market your devices in the UK or in Switzerland, this company needs to have representatives in these 2 countries.
Easy Medical Device is a company that has offices in EU, UK and Switzerland and can act as Authorized Representative and Importer. This helps you avoid having to appoint multiple partners, as we take charge of all the activities for the three regions, and you’ll have 1 point of contact in case of issues.
Easy Medical Device is also a consulting firm that helps manufacturers to prepare all the documentation needed to be compliant for each markets. Don’t hesitate to inform our team if you need support.
For Authorized Representative, we are collecting all the information needed to confirm that we will accept the mandate that you’ll give to us. There are strict responsibility mentioned on the regulation and we need to be sure that your company is following all the rules prior to place your device on the market.
We are then preparing the information to register within each governments.
For importer, there are more logistic needed and we need to prepare your structure for it. We have to verify each product that enters the region and then approve them for release. We don’t have to receive physically the products but we need to receive from your side all the documentations that proves that you are compliant. A training to your team will be provided.
To help you, Easy Medical Device need to understand your situation. For that we ask you to provide us few details about the products that you want to market so we can come back to you with the best offer. Please fill out the form below and submit that to our team. After reception of the quote, if this is satisfactory for you, we will plan a meeting to move further in the process.