Why claim equivalence?
In the complex landscape of EU MDR, the concept of equivalence is a powerful tool for manufacturers. Demonstrating equivalence can significantly streamline the clinical evaluation process, leveraging existing data to expedite market entry and reducing the need for new clinical investigations.
How to claim equivalence
Do you intend to claim equivalence by using data pertaining to an already existing device on the market, for the purpose of CE-marking under the EU MDR? If so, there are three main aspects to consider:
1. Does your device fulfil the Clinical Characteristics for claiming equivalence?
The intended use and clinical condition of the device should be the same. This includes indications, patient population, and the medical conditions the device addresses. Differences in clinical performance should be justified with additional data.
2. Does your device fulfil the Technical Characteristics for claiming equivalence?
The technical design and specifications should be comparable. This includes materials, software, and performance specifications. Any variations should be clinically insignificant or adequately justified
3. Does your device fulfil the Biological Characteristics for claiming equivalence?
The biological compatibility should be equivalent, ensuring that materials in contact with the body do not pose additional risks. This is particularly crucial for implants and devices with direct body contact.
NOTE: For all Class III and Implantable Devices: a contract signed by the two manufacturers and allowing full access to the technical documentation of the equivalent device should be provided to the Notified Body.
Challenges of claiming equivalence – What has Advena UK experienced?
Demonstrating equivalence (unless between a legal manufacturer’s own variants) is not straight forward. We have worked with numerous clients who have received rounds of questions when they have attempted to claim equivalence. Technical and Biological characteristics are the hardest to demonstrate equivalence unless competitor materials and manufacturing methods are known. Equally any differences in indications, patient populations or medical conditions can prevent clinical characteristic equivalence being claimed.
What can I use historical ‘equivalency’ data for?
Manufacturers of legacy devices previously certified under EU MDD may have previously taken the equivalency route for their clinical evaluation. Whilst equivalency may not be an option under EU MDR, all of the information previously gathered can be used to support state-of-the-art, relevant to similar devices.
How can Advena UK help?
1. Expert Guidance and Strategic Planning- helping you identify potential equivalent device/s and develop a robust equivalence strategy tailored to your specific device.
2. Comprehensive Comparative Analysis- a thorough analysis of clinical, technical, and biological characteristics between your device and the equivalent device/s. Ensuring all aspects of equivalency can be demonstrated.
3. Robust Documentation Preparation- help prepare comprehensive and well-structured clinical evaluation to document equivalence claims. Collection and presentation of robust clinical data from the equivalent device, supplemented with any available data for your device, providing scientific justifications for equivalence claims, including thorough risk analysis and mitigation strategies.
In addition, we can also provide:
- Full technical documentation review/creation
- Assistance with regulatory submissions and interactions with regulatory authorities
- Training/knowledge transfer
- ISO13485 Quality Management System creation, management and support
