Economic Operator Services
We help you meet these European regulatory requirements
|Article 13 of the EU MDR and IVDR
|UK Medical Device Regulations
|Switzerland MedDo Regulation
|Great Britain Importer
|EU Authorized Representative (EAR) Required under Article 11 of the EU MDR/IVDR.
|UK Responsible Person (UKRP) Required for selling in England, Scotland and Wales.
|Swiss Authorized Rep (CH-REP) Required for all companies without a location in Switzerland.
The Medical Device & IVD market landscape is in constant flux with changes to medical device regulations & shifting customer dynamics elevating the role of the Economic Operator in the EU, UK and Switzerland. Partnering with Shiro Business solutions and MedEnvoy, independent importer services company, can bring you many benefits over a local distributor. Not least, we can act as your single independent importer for the markets mentioned earlier.
We are no strangers to the medical device and IVD industry. The MedEnvoy seasoned executive team has been working with device companies worldwide for decades. MedEnvoy fully understands the complexities of managing and controlling your European supply chain along with the new regulatory requirements imposed by the European Commission, UK MHRA and Swissmedic. We are ready to help you maintain compliance and the seamless flow of your products throughout the region.
Commercial Flexibility Preservation
EU MDR medical device labelling requirements dictate that all medical devices must identify the name and address of the Economic Operators. If you select a distributor to act as your importer and then decide to part ways with them, you will be forced to reprint all of your labelling for all of your medical devices & IVD devices on the market. Partnering with Shiro Business Solutions gives you the flexibility to change distributors later without needing to do this.
100% Focus on Service, not Logistics
Our focus at Shiro Business Solutions is on making sure medical device & IVD companies are 100% compliant with EU, UK and Swiss regulations. Logistics aren’t our thing. We don’t have a warehouse, handle your products, and most importantly, we don’t slow down your shipping process. We use technology to speed up compliance checks, ensuring no redundant activities are performed between your authorised representative and your distributor.