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UK REPRESENTATION
When choosing a UK Responsible Person, it's vital to opt for a trustworthy and knowledgeable partner well-versed in the regulatory environment, capable of fulfilling the manufacturer's obligations effectively. Selecting Amstermed as your UK Responsible Person ensures a reliable advisor committed to ensuring compliance with the UK MDR 2002. This choice safeguards not only the manufacturer's reputation but also the safety of the devices in the market.
The role of the UK Responsible Person is pivotal in ensuring the safety and compliance of medical devices in the Great Britain market. Amstermed, as the UK Responsible Person, serves as a liaison between the non-UK manufacturer and regulatory authorities. Their responsibilities include facilitating the registration process and furnishing essential documentation.
APPOINTMENT AND RESPONSIBILITIES OF A UK RESPONSIBLE PERSON
The UK Responsible Person is required to furnish written evidence affirming their authority to represent the manufacturer.
By selecting Amstermed as your UK Responsible Person, non-UK manufacturers can adeptly navigate the regulatory prerequisites for introducing medical devices to the Great Britain market.
Amstermed, in its role as the UK Responsible Person, actively fulfills obligations, ensures compliance, and collaborates with regulatory authorities on behalf of the manufacturer. It is imperative to include the UK Responsible Person's details on product labelling or packaging to meet the specific requirements of the UK market.
- Registering the manufacturer's devices with the Medicines and Healthcare products Regulatory Agency (MHRA) before they can be placed on the Great Britain market.
- Keeping copies of the technical documentation, declaration of conformity, and relevant certificates, including any amendments and supplements, available for inspection by the MHRA.
- Providing the MHRA with all necessary information and documentation to demonstrate device conformity upon request.
- Complying with any requests from the MHRA to provide samples of the devices or access to the device, if available.
- Communicating to the manufacturer any MHRA requests for samples or access to the device if they do not have them, and conveying whether the manufacturer intends to comply.
- Cooperating with the MHRA on any preventive or corrective actions taken to eliminate or mitigate risks posed by the devices.
- Immediately informing the manufacturer about complaints and reports from healthcare professionals, patients, and users regarding suspected incidents related to a device for which they have been appointed.
- Terminating the legal relationship with the manufacturer and informing the MHRA and the relevant Approved Body if the manufacturer acts contrary to its obligations under the regulations.
The name and address of the UK Responsible Person, when applicable, should be featured on the product labeling, outer packaging, or instructions for use if the device carries the UKCA marking.
For devices solely bearing the CE marking, inclusion of UK Responsible Person details is unnecessary, unless both the CE and UKCA markings are present.
- Choosing a UK Responsible Person is critical, and it's essential to opt for a reputable and reliable partner familiar with the regulatory landscape to effectively fulfill the manufacturer's obligations.
- Selecting Amstermed as your UK Responsible Person ensures a trusted advisor role, guaranteeing compliance with the UK MDR 2002. This choice not only protects the manufacturer's reputation but also ensures the safety of the devices on the market.
