UKRP Services: Streamlining Compliance and Market Access for Medical Device Manufacturers in the UK
As a UK Responsible Person (UKRP), AF Pharma takes on crucial responsibilities on behalf of medical device manufacturers, ensuring compliance with legal obligations within the UK market. Our dedicated UKRP services encompass a range of tasks aimed at facilitating successful market access and regulatory compliance.
Key Responsibilities of a UKRP:
1. Device Registration: The UKRP is responsible for registering the manufacturer's devices with the Medicines and Healthcare products Regulatory Agency (MHRA) prior to their introduction into the UK market.
2. Compliance Assurance: AF Pharma ensures that the manufacturer's device declaration of conformity (DoC) aligns with regulatory requirements. We also verify that the technical documentation meets the necessary standards and that an appropriate conformity assessment procedure has been carried out.
3. Documentation Maintenance: The UKRP keeps readily available copies of essential documents, including technical documentation, the declaration of conformity, and relevant certificates (including amendments and supplements), to provide to the MHRA when requested.
4. Information Provision: Upon request, the UKRP promptly responds to the MHRA, providing all necessary information and documentation to demonstrate a device's conformity with regulatory requirements.
5. Cooperation and Action: AF Pharma actively collaborates with the MHRA, participating in any preventive or corrective actions to eliminate or mitigate risks associated with devices. We also ensure immediate communication with the manufacturer regarding complaints and suspected incidents related to designated devices, as reported by healthcare professionals, patients, and users.
6. Legal Relationship Termination: In cases where the manufacturer acts contrary to its obligations under the applicable Regulations, the UKRP has the authority to terminate the legal relationship. AF Pharma promptly informs the MHRA and, if applicable, the relevant 'UK-Approved Body' about such termination.
Importers and UKRP Relationship:
When a manufacturer utilizes a UK importer who is not the UK Responsible Person, the importer must inform the designated UKRP of their intention to import the device. In turn, the UKRP provides the MHRA with a comprehensive list of device importers. While importers must adhere to existing obligations concerning storage, transportation, and device label verification, the importer's name and address need not be present on the label unless the importer or distributor acts as the UKRP.
By entrusting AF Pharma as your UKRP, you gain a dedicated partner who ensures regulatory compliance, facilitates market access, and upholds the highest standards of quality and safety for your medical devices in the UK.