MDR Certification

 

Tenscare are proud to be MDR Certified

TensCare Ltd is an EU Medical Device Regulation (EU) 2017/745 certified company. TensCare has been EU MDR compliant since 2021 and continue to undergo auditing processes and reviews by BSI, who thoroughly assessed our technical documentation and compliance to the regulation.

What is EU Medical Device Regulation (EU) 2017/745?

EU MDR is the Internationally recognised regulation to market any class of medical device in a member state of the European Union. The EU MDR replaced the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) in May 2017.

This regulation classifies all medical devices excluding in vitro diagnostic devices into 4 classes based on the level of risk the device holds.

The regulation was implemented to increase and tighten the requirements for medical devices placed on the EU market and ensure the safety and effectiveness of medical devices in the best interest for the customers.

EU MDR compliance demonstrates a commitment to ensuring customer safety and product reliability. It demonstrates the manufacturers efforts to ensure design, development, production, and delivery of medical devices are safe for their intended purpose.

What are the benefits of EU MDR?

• All supplied components/materials for the manufactured devices are constantly inspected to ensure performance and acceptability as to not affect the quality of products is not affected
• Ensures safety and efficiency of the product as manufacturer’s must be continuously audited for compliance
• MDR applies stringent safety and performance standards in device design and development. Each device is backed by scientific evidence, undergoes rigorous testing and incorporates valuable insights from user feedback data, enabling the development of innovative health and wellbeing solutions that effectively and safely treat conditions, enhancing quality of life.

• Buyers should not be simply satisfied with EN 60601 safety certification but should enquire that their supplier is compliant with the latest standards
• Failure to do this can leave them open to liability of using or supplying on to their customers medical devices that are not assured to be conforming to the latest applicable standards.
• TensCare's EU MDR accreditation assures all medical devices meet all current safety standards and business practises.

For a supplier to meet MDR signifies adherence to a set of internationally recognized criteria established EU. This commitment extends across various aspects of the supplier's operations, including product quality, environmental management, occupational health and safety, and information security, among others. Meeting standards implies that the supplier has implemented robust processes and controls to ensure consistency, reliability, and compliance with specified requirements. It signifies a dedication to continual improvement, customer satisfaction, and alignment with global best practices. Ultimately, for a supplier, meeting EU standards is not just about obtaining a certification; it's about fostering a culture of excellence, accountability, and trust throughout their organization, enhancing their reputation, and providing assurance to customers and stakeholders.

What does it mean for customers?

• Increased Confidence in Product Quality: MDR mandates stricter requirements for the design, manufacture, and testing of medical devices. As a result, distributors can have greater confidence in the quality and safety of the products they distribute, reducing the risk of liability and product recalls.
• Enhanced Market Access: Compliance with MDR standards allows distributors to access the European Union (EU) market more easily. This opens up opportunities for expanding their customer base and reaching new markets within the EU member states.
• Streamlined Regulatory Processes: MDR introduces standardized regulations and documentation requirements across the EU, simplifying regulatory compliance for distributors who operate in multiple member states. This streamlining of processes can lead to cost savings and increased efficiency in managing regulatory affairs.
• Improved Supply Chain Transparency: MDR emphasizes transparency and traceability throughout the supply chain, requiring comprehensive documentation and labelling of medical devices. Distributors benefit from clearer information about the products they handle, facilitating better inventory management and risk assessment.
• Competitive Advantage: Demonstrating compliance with MDR standards can serve as a competitive advantage for distributors. It signals to customers and stakeholders that they prioritize product quality, safety, and regulatory compliance, distinguishing them from competitors who may not meet these standards.
• Reduced Risk of Non-Compliance: By adhering to MDR requirements, distributors mitigate the risk of distributing non-compliant or unsafe medical devices. This helps protect their reputation and brand integrity while reducing the potential for legal and financial consequences associated with non-compliance.
• Opportunities for Collaboration: MDR encourages collaboration and communication between distributors, manufacturers, and other stakeholders in the medical device industry. Distributors can benefit from closer partnerships with manufacturers to ensure compliance with regulatory standards and address any compliance-related challenges together.

Overall, MDR offers distributors in the medical device industry numerous benefits, including increased confidence in product quality, enhanced market access, streamlined regulatory processes, improved supply chain transparency, competitive advantage, reduced risk of non-compliance, and opportunities for collaboration within the industry.