As we complete regulatory submissions under MDR, we continue to learn from notified body feedback and audit findings. These lessons learned are captured and disseminated throughout the RQM+ team to build our unrivaled collective knowledge, but we also believe in sharing this valuable information with the industry. Here is what we have learned so far from notified body technical documentation audits under MDR.
As the MDR audit findings begin pouring in, manufacturers are learning that the notified bodies have not been bluffing. The expectations for compliance and a high level of detail in documented evidence are far more than what was experienced with MDD before 2020. Additionally, the notified bodies are expecting corrections to be made in a much shorter time frame compared to the 6-12 month period that was often acceptable in previous years (provided there were no concerns of product safety). This combination of stringently adhering to regulations and expecting quick changes is leaving many manufacturers scrambling to comply.
Although there may be a temptation to “test the waters” by submitting documentation that embraces the spirit of the regulation but has some technical gaps, notified bodies aren’t exhibiting leniency and won’t accept that approach. Given that there are only three rounds of review, manufacturers will want to use that feedback wisely.
Technical Documentation Nonconformities
MDR provides the foundation for the details of the technical documentation to be provided by manufacturers, but there is plenty left to interpretation. The regulation specifies that information should be presented in a clear, organized, readily searchable, and unambiguous manner—this is what notified bodies to expect. Before submitting, manufacturers must carefully review their technical documentation packages to ensure that all elements are present and appropriate for the device under evaluation. Reviewers are indeed examining every detail, so it pays to be rigorous in your document preparation.
In the audit findings we have seen to date, technical documentation issues have been highlighted in four distinct categories:
1. Device Description and Specification Nonconformities
Every detail matters in a regulatory submission, and notified bodies are closely examining information pertaining to the device description and specifications. Some of the nonconformities we have seen include:
- Intended use, intended purpose, and target patient population not clearly defined
- No explanation of device history, previous versions, or principle of operation
- No listing of all variants and compatibility between components
- Not including a bill of materials with all raw materials, packaging materials, IFUs, labels, cartons, and so on utilized in manufacturing
- No packaging drawings included in the referenced sections
- Inclusion of standards that don’t apply to the subject device
- Failure to reference the latest versions of standards
2. Testing Nonconformities
Testing on product samples equivalent to the finished product continues to be required under MDR. To that end, data selection and product testing approaches must be carefully considered, and manufacturers should always be prepared with a justification and rationale for their product testing strategy. Nonconformities related to testing that have been identified by notified bodies include:
- Failure to explain how a representative worst-case device was chosen for biological testing
- Lack of clarity on whether a representative device has the same material specification as the subject device under review
- Failure to include a standards list with all harmonized and non-harmonized ISO, ASTM, and other international standards, including for materials, functional testing, packaging/transport testing, and so on that are the current state of the art
- Failure to define the product lifetime
- Failure to perform design validation testing for the product lifetime
3. Risk Nonconformities
MDR requires manufacturers to establish, document, implement and maintain a system for risk management that meets the criteria defined in Annex I, which aligns with ISO 14971. Although there are currently no harmonized standards under EU MDR, notified bodies are considering ISO 14971:2019 to be state of the art and therefore expecting compliance.
Manufacturers must have a documented risk management plan; identify and analyze the known and foreseeable hazards; estimate and evaluate the associated risks; and eliminate or control those risks for each device. Once in the production phase, manufacturers must continue to evaluate the impact of new information and amend control measures as needed.
Nonconformities that notified bodies have identified related to risk include:
- Failure to provide risk management plans for each device
- Failure to include the subject device in the risk management plan that was provided
- Failure to adequately address risks associated with time, process, and clinical use
4. General Safety and Performance Requirements (GSPR) Nonconformities
The general safety and performance requirements (GSPR) under the MDR replace the essential requirements under MDD. The requirements covered in Annex I of the MDR have been formulated more precisely, with the scope and detail of the requirements considerably increased. However, the scope of notified body observations seems to follow one general theme: justification of applicability.
Notified bodies have identified the following nonconformities related to GSPR:
- Lack of clarity on how specific GSPR sections have been addressed in the labeling and IFU
- Lack of clarity on why specific GSPR sections were identified as applicable for the devices under review
- Lack of clarity on why specific GSPR sections were identified as not applicable for the devices under review
Unrivaled Collective Knowledge
RQM+ has supported EU MDR implementations and tech doc submissions since 2018, building our unrivaled collective knowledge with extensive and diverse experience across clinical specialties, device classes, and notified bodies.
Following every project, we update our internal systems and educate our team members to ensure that all of our clients continually benefit from our experiences.
If you need help with MDR or IVDR technical documentation, RQM+ is here to help. Contact us today for a consultation.