Whether you are used to working with a notified body or the MDR/IVDR requirements no longer allow you to self-certify and it’s all new to you, it is more important than ever to optimize your technical documentation. Notified bodies are already swamped with MDR submissions, and as the IVDR deadline approaches and new manufacturers engage them, the bottlenecks will get even tighter for IVD NBs.
In addition to handling more volume, the requirements are also more stringent, which is leading to both closer scrutiny and longer review periods. Any steps you can take to optimize your technical documentation will help ensure that your products stay on the market. A successful submission calls for not just understanding EU MDR technical documentation requirements but also taking any steps you can to make it easier for notified bodies.
Why Optimize Your Technical Documentation?
The main reason to invest resources into optimizing technical documentation is to avoid or minimize audit findings. Every finding requires a reaction that will continue to burden resources, including additional time and costs from the notified body. If you get it right the first time, you can focus your resources on daily operations, new product development, or whatever your current priority is. Optimizing your technical documentation also helps you minimize future maintenance by making it easy to update and as simple as possible.
With only three rounds of questions allowed, you want to be sure that you don’t waste precious time on avoidable mistakes. In the past, notified bodies would let minor administrative issues slide. Notified bodies no longer have time to solve administrative problems in technical documentation and they will not organize your files for you. However, the funnel is only so big, and only so many files can go through at the same time, so it’s important to submit files early for the first review. If you wait until 12 months prior to the submission deadline, you risk delays that could affect your ability to keep your medical device or IVD on the market.
When you produce high-quality technical documentation you also have the potential to reduce the time to market because it leaves you more time to implement. After you get certification from your notified body, you still need to finalize labeling, get a CE mark, and submit a declaration of conformity. This often takes more time than people expect. When you minimize audit findings and questions, you get approved faster and have more time to implement, which reduces pressure on manufacturing.
Notified Body Audit Findings for MDR
The notified body audit findings we are receiving for MDR can inform future technical documentation submissions under both MDR and IVDR. When you get a request, your response should be really strong and satisfy the reviewer’s intent. You don't want to waste a round of questions on reiterating the same thing, so make sure your response is compelling.
Some of the nonconformities in technical documentation we have seen so far include:
Missing or insufficient elements of device description and specification, such as:
- Clear definition of intended use, intended purpose, and target patient population
- Explanation of history of device/previous versions, the principle of operation
- Listing of all variants and compatibility between components
- Manufacturing details, for example, bills of materials
- Packaging drawings in the referenced sections
- Lists of standards applicable to the device
- Reference to the latest versions of the standards
- Justification for partial compliance of standards
Examples of nonconformities around testing include insufficient:
- Explanation of selection of worst-case representative devices for testing
- Material specification consistency between representative device and subject device
- State of the art standards list for materials, functional testing, packaging, and transport testing
- Design validation testing for the lifetime of device
Nonconformities around risk include:
- Risk management plans are not available at all
- The subject device is not included in the risk management plan
- Process and clinical use risk analyses are missing or inadequate
- Risk management files have not been updated recently
- The risks are not aligned with post-market data and clinical data
Nonconformities around general safety and performance requirements (GSPR) include:
- Lack of clarity on how specific GSPR requirements have been addressed on labeling and instructions for use (IFU)
- Clarification about why certain GSPR requirements are applicable to the device under review
- Justification of why certain GSPR requirements are not applicable to the device under review
- Insufficient traceable documents to support compliance with GSPR
These are just a few examples of the types of nonconformities that are potentially avoidable if you take the time to optimize your technical documentation. Other areas to pay close attention to include clinical and post-market documentation as we have seen findings in these categories as well.
Practical Tips for Meeting EU MDR Technical Documentation Requirements
If your goal is to reduce notified body review time and questions, we recommend some practical tips for optimizing your technical documentation. It’s best to be aware of specific technical requirements for submitting your documentation at the outset so you can set up your systems to comply and save time when preparing your submissions. Allow time for digital publishing and use a skilled person who knows how to meet the requirements for:
- File sizes
- File formats
Additionally, use templates that ensure you have consistent administrative data throughout your documentation, including company and product names, aliases, version numbers, and so on.
Understanding how notified bodies review your submissions can also help you optimize them. Assume that multiple people will be reviewing sections of your files and that no single person will be reviewing everything. To that end, parse your files for multiple reviewers and provide consistent and thorough administrative data in each section. Even though it may seem repetitive, this will be valuable to the individual reviewers who are not looking at the entire file as a whole. You should also assume that notified bodies are looking for full reports and not summaries, so include as much relevant data as possible.
Each notified body has its own acceptance checklist so review it at the outset and follow it closely. Before submitting your documentation, cross-reference with the checklist to ensure all requirements are covered.
When possible, follow MDCG guidance documents when they exist. Even when guidance does not exist for a particular requirement, it helps to understand the guidance in other areas to get a sense of how the MDR and IVDR are being interpreted. You can also learn from prior submissions to become familiar with what types of nonconformities notified bodies are identifying so you can avoid making the same mistakes. This is one of the key advantages of working with a consultant.
How RQM+ Helps
Our spectrum of services ranges from providing dedicated resources for discrete tasks to strategic guidance to full managed services and everything in between. We have experience creating and maintaining technical documentation across all device types and clinical specialties. Specific services include:
- MDR/IVDR technical documentation
- Gap analysis
- Ongoing support after the initial file has been created
- Response to notified bodies
- Remediation of files that are not compliant
With former regulators and notified bodies on staff, we have insights into what reviewers are looking for. This helps you save time with less guesswork so you can get your products to market faster and with less burden on your resources. You also benefit from our unrivaled collective knowledge that grows with every project we complete. Our team has submitted hundreds of technical documentation files under MDR/IVDR and understands how to optimize them using best practices and finely honed tools.
If you need support meeting EU MDR technical documentation requirements and creating the best possible submissions, our team is here to help. Contact us today to schedule a consultation.