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The purpose of this SOP is to describe the offering and sale of medical devices provided by the organization with the purpose of only allowing the sale of medical devices that comply with appropriate and relevant regulatory requirements of the region intended.
This SOP covers the sales of medical device products.
The business team and/or the sales team will primarily be responsible for the creation and maintenance of the marketing material for medical devices. The marketing material refers to all claims regarding the functionality, usability, safety, and performance of the medical device. Any claims that are to be used for a medical device are required to undergo review and approval by the quality team. The business team is responsible for keeping marketing materials up to date. Marketing materials can include but are not limited to brochures, fliers, advertisements, presentations, speeches, and white papers.
According to MDR 2017/745 Article 7, in the labeling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
According to IVDR 2017/746 Article 7, in the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
All performance claims must be substantiated by and align with the results presented in the device's Performance Evaluation Report.
The organisation's sellable products is defined as all medical products and services that are released for marketing and sales following product certification and registration under the local laws according to Regulation (EU) 2017/745 (MDR). Only those products that have undergone product registration through SOP Product Registration and Certification can undergo sales.
The organisation's sellable products is defined as all in vitro diagnostic medical products and services that are released for marketing and sales following product certification and registration under the local laws according to Regulation (EU) 2017/746 (IVDR). Only those products that have undergone product registration through SOP Product Registration and Certification can undergo sales.
According to Medizinproduktedurchführungsgesetz (MPDG) Section 83, any person who provides technical information to experts or instructs them in the proper handling of medical devices on a professional basis is required to be trained as a medical devices consultant. This includes the following required expert knowledge:
The medical devices consultant shall furnish the competent authority, upon request, with proof of his/her expert knowledge. The medical devices consultant shall have up-to-date knowledge of the specific medical devices so as to be able to provide competent advice.
The medical devices consultant will receive training at least once per year regarding the specialized medical devices they provide training for or instruction on which will be documented as part of the QMS processes for training.
The business team is responsible for developing and maintaining all marketing and sales content. Any claims regarding device performance and safety must be pre-approved before being included in marketing materials. All other marketing content should be reviewed to ensure alignment with regulatory definitions outlined in Sections 3.1 and 3.3.
Marketing statements must accurately reflect the device specifications as defined in the technical documentation.
If a device undergoes modifications or updates per the change management process, the business team must evaluate whether these changes impact existing claims. Any new claims associated with product changes require prior approval.
Only validated marketing claims related to performance and safety may be shared with customers. If a customer requests additional information that is not significantly different from the approved marketing content, it may be provided. However, if the requested information is not covered in existing marketing materials and is critical to product understanding, it must go through the approval process outlined in Section 3.1 before being shared.
Customer contracts should be considered on a customer basis. When a customer that is a business expresses interest in purchasing a product from the company, the business team assesses the feasibility of fulfilling the request.
This includes evaluating:
• Product availability and compatibility with the customer's requirements
• Capacity for service delivery and post-sales support
• Regulatory considerations that may impact product distribution
• Compliance with IVDR-specific requirements, such as restrictions on distance sales (Article 6) or sales to specific user groups (e.g., professional use only vs. near-patient testing).
If the company determines that it can meet the customer's needs, the business team drafts and delivers a contract proposal outlining the terms of the agreement if needed by the customer.
All contracts must be recorded in consectetur adipiscing for tracking and compliance purposes. Customer support shall be provided according to the regular customer feebdack channels at the company and an appointed customer service representative may be implemented if required.
Deployment of the device shall be performed according to SOP Deployment, if appicable.
