Service

UK Responsible Person
According to the UK MDR 2019 the UK Responsible Person is defined as “a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.

Responsibilities
The requirements of the UK Responsible Person are the same as for a European Authorised Representative. The UK Responsible Person must:

Ensure that the 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.

In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.

Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.

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.

Keep available a copy of the technical documentation, 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 MHRA.

Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination

Medical Device Importer & Distribution
Our team has been integrating the local resources and facilities to support our partner on import/export, logistic, warehousing and sales management. 

We provide Safety and Efficiency
Pan-UK and EU distribution and logistics are not straightforward from time to time, especially for medical equipment, there are regulations, policies that make the vendors feel complicated, therefore it might pause/slow down their business expansion. We, as Wings Medical, would love to explore solutions for each partner to support them in their business. 

Safety & Compliance
Our logistic team and warehouse are MHRA approved and GDP compliant. in the meantime, our facility is 24-hr CCTV monitored with strict entry control. By doing this, we provide best in class services to make sure your goods are safe. 

Efficiency
Our warehouses could provide UK next day delivery and EU within 72-hour delivery, our online sales team is aiming to provide the fastest support so that the products will be seamlessly integrated throughout our sales system and channels.

Billing & Invoicing
Wings Medical has been authorised as an official medical equipment importer by MHRA, as well as equipped with UK VAT number and EORI number, which supports free movement of the medical products within the UK and EU territories.