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
The new 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 risk management section of medical device technical files is significantly impacted by the new MDR regulation. This section must now include records of all non-serious incidents, data on any “undesirable” side-effects, information on all the proactive and systematic processes to collect all post-market information, indicators and threshold values for the continuous reassessment of the benefit- risk analysis, and much more. The amount of additional risk information required for each device is perhaps the area of largest impact on the product technical files. New systems and processes will first need to be put in place before much of the new information can possibly be identified and collected, if it was not already meeting this higher standard. Readiness to comply with this area of the new MDR regulation can take anywhere from a few months to a more than a year, depending on the current level of detail a manufacturer is capturing in the post-market device information. For example, if non-serious incidents related to device use are not currently being tracked, the manufacturer will first need to train their clinical and sales teams that represent the device in the field on what information needs to be documented, and then determine an effective implementation plan.
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.
Celegence can provide you with subject matter experts, including both regulatory professionals and medical doctors with relevant device expertise to complete this work for you or supplement your internal team as needed. For more information, reach out to us at email@example.com.