The New European Union MDR: Impact on Technical Files
The following is the second in the series of blogs related to the recent updates to EU MDR. Read the 1st post about understanding medical device equivalence vs demonstration of equivalence. You can view the 3rd post about post the new post market clinical follow up requirements for EU MDR.
The new EU MDR requires technical documentation to include a substantially larger amount of information on all aspects of the medical device. In some areas, such as risk management, manufacturers will need to first implement new and more detailed systems and processes before much of the newly required information can even be identified and collected. This poses a risk to all device companies for compliance readiness – companies that have a product portfolio focused on lower risk devices as well as companies that focus on higher risk devices.
Celegence can provide expertise on implementing processes for medical device design and development, manufacturing, and post-market surveillance for technical file compliance with the new MDR regulation, as well as provide experienced resources to create and remediate product technical files.
Device Description and Product Specifications
The new MDR requires the product’s technical documentation to include more information within the section that covers the Device Description and Product Specifications. The new requirements for this section include information on the composition of the complete device (as opposed to just the significant components), transparency of all operating principles of the device, detailed profiling of the intended users of the device, and additional considerations to be answered that profile the risk classification of the device.
Regarding the intended users of the device, the new MDR now requires that the technical file include precise identification of the intended patient population, the medical conditions relevant to the use of the device, as well as acknowledgement of specific patient selection criteria.
This section of the technical file will also need to include an official written justification for the decisions made on the risk profile of the device and the classification rule(s) applied to the device, as well a description of all raw materials incorporated into key functional elements of the device (not just components of the device that affect biocompatibility).
Manufacturers must also include in this section of the technical file a written rationale for the qualification of the product as a device.
Device Design and Manufacturing Information
The technical documentation that covers the device design and manufacturing information is also impacted by the new MDR regulations. The design information for the device must now describe the complete design process used, as well as the design controls that are in place for the device’s development. The manufacturing section of the technical file must now include complete information on all manufacturing processes used, as well as their validation. Manufacturers must also identify all suppliers and sub-contractors involved with the design and manufacturing of the device, not just “critical” suppliers and sub-contractors.
Pre-Clinical Verification and Validation Information
The section(s) within the technical file that cover the device’s pre-clinical verification and validation information are also impacted by the new MDR regulation. The focus of this information is still on device’s safety and performance, but there is substantially greater detail in the information required. This section must now include a critical analysis of all verifications and validation tests and results, as well as the complete testing protocols. The new MDR regulation also requires some mandatory pre-clinical data, which includes all of the following:
- Physical, chemical and microbiological characterization
Electrical safety and electromagnetic compatibility
Software verification and validation
Stability and shelf life
Performance and safety testing
Proof that the device conforms to the general safety and performance requirements when connected to any indicated other device(s)
The technical documentation on clinical evidence for the device will also require more information to comply with the new MDR regulation. This section must now directly include the clinical evaluation plan and the post-market clinical follow-up plan and report… references to this documentation being contained elsewhere will no longer suffice. Additionally, the clinical evidence section must now include proof on the manufacturer’s processes for effective communication with competent authorities, notified bodies, economic operators and users, as well as procedures to fulfill all the manufacturers’ obligations.