You’ve probably heard the news.
The NBs don’t have the capacity to assess and renew all the certificates expiring in 2024 in time.
According to a recent survey, at least 50% of the technical documentation submitted to NBs was considered incomplete, and additional information needed to be requested to start the assessment.
The rulemakers are urging manufacturers to submit their MDR application soonest possible to their NB, with quality that meets the NB’s assessment criteria. Doing so would give manufacturers some chance of obtaining certification under the MDR before their old certificate expires, and thus they could avoid a major interruption in getting their devices to patients and users.
While the message is clear, it’s not always easy to follow.
Working with clients, I’ve witnessed how getting technical documentation up to MDR speed is an enormous project for manufacturers. Especially under tight schedule.
But every small step to the right direction counts.
I want to share some practical tips I’ve seen have helped manufacturers to complete legacy device technical documentation for the NB review faster.
Create templates early
If you’ve been used to seeing your device and the industry requirements through MDD glasses, it can be difficult to adjust your eyes to the MDR. You may struggle to really understand what’s changing. For example when technical documentation is concerned. When time’s running short for legacy device manufacturers, they need every aid to make the adjustment quicker.
What I see working well with my clients is to have the document templates that follow the relevant MDR requirement, guidance and/or harmonised standard available early on. Templates help visualise the new requirements. This typically sharpens the focus of what they’re doing and leads to more efficient spending of time in the MDR project.
Don’t leave GSPR to the last minute
I’ve noticed that manufacturers rarely pick GSPR checklist as the first or even second MDR technical document they work on. They usually prioritise other documents instead. This typically results in a lot of going back and forth between documents and even strategic decisions sometimes being re-considered late in the project. The reason is that the fundamental MDR requirements embedded in the GSPR surface late.
To avoid doing things inefficiently backwards, I take up the GSPR checklist early with my clients. I’ve seen the difference that GSPR on the table from the start makes. Manufacturers are able to finalise the technical documentation submission on schedule or sometimes even ahead of schedule.
Risk management file before clinical evaluation
The risks of a medical device have a significant effect on its clinical evaluation. Determining if the device’s benefit-risk profile is acceptable is a key element in clinical evaluation. To not have an up-to-date understanding of the current clinical risks, will delay the completion of clinical evaluation. And that has a domino effect on the PMS, PMCF, IFU, labelling, etc.
I get that MDR technical documents need to be managed in parallel, as everything is connected. Having said that, bringing the risk management file to a mature MDR state before the clinical evaluation kicks off, makes the clinical evaluation go smoother and faster. There won’t be as much need to redo things, but to keep going towards the finishing line.
Check consistency repeatedly
The NB reviews the technical documentation for accuracy and completeness. If they find key information inconsistent or missing, they will report it to you. This will pause the NB review. Even if you fix the flaws in reasonable time, your NB reviewer might not have a slot right away to resume the review. When the CE certificate expiry is close, you don’t want any delays.
What I do with my clients is that we arrange essential information checks regularly across documents. We follow closely the guidance from the NB in question to meet their specific expectations. This way the manufacturer can save time and improve the chances of having their CE certificate renewed in time.
By bringing in the MDR-proof technical document templates early in the process, using the compass of your MDR journey – the GSPR – also early on, revising the risk management file before the clinical evaluation and not forgetting to check essential information is available and aligned everywhere, you can complete legacy device technical documentation for the NB review faster and improve your chances of continuing selling your device without interruptions.
What are your go-to tips besides these ones here? I’d be happy to read your comments.
And if you have any questions about MDR technical documentation, please send me a message and we’ll talk.