Export from U.S. / Import into U.K.
For companies outside of the UK wishing to get started there, RAF Solutions USA has offices in the UK and are experts in helping to navigate the complexities for companies wishing to expand their business, especially in medical device business. We have the necessary expertise to make your expansion a success.
EU importer of medical devices:
- If you are looking to expand your business by exporting your medical device to the UK, you have to comply with the new Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
- The MDR and IVDR introduce an economic operator (EO) regime covering the entire supply chain to the end-user. It includes the manufacturer, authorized representative, importer, and distributor. We focus on the role of the UK importer of medical devices and combine this with our services and extensive knowledge to create a level playing field for non-UK manufacturers.
What has changed?
- The new MDR and IVDR brings UK legislation into line with technical advances, changes in medical science, and progress in law making. It creates a robust, transparent, and sustainable regulatory framework, that is internationally recognized and reduces the risks of discrepancies in interpretation across the UK market.
- In general, the MDR and the IVDR keep all the requirements of the Directives, while adding some new requirements of their own. Compared to the current Directives, the new Regulations emphasize a life-cycle approach to safety, backed up by clinical data.
- The Regulations add more stringent rules for the designation of Notified Bodies. For national competent authorities and the Commission, they add more control and monitoring requirements. Other important parts of the regulations clarify the obligations of manufacturers, authorized representatives, importers and distributors.