The difference between getting it right and getting it wrong is time lost. And time is of the essence. Fixing any errors or inconsistencies within technical documentation creates unnecessary delays in the certification process or, in many cases, recertification. But compliance isn’t the only reason to get it right – it can also bring business benefits.

In this blog post, we’ve put together a brief guide to what you should know, and what you might not need to know, when compiling the technical documentation for MDR.

What You Should Know

There are two important reasons for medical device manufacturers to ensure their technical documentation is correct. Firstly, it’s mandatory to compile all the relevant evidence to prove that a product is functional, efficient, and safe. Secondly, it needs to be easy for Notified Bodies to check and approve your compliance to the MDR. However, producing a technical dossier that’s compliant with MDR can also add long term value to your product. So here are 5 things you should know about getting your technical documentation first time right for the MDR:

1. Development Plan

Medical devices need to be carefully designed and supported with the right technical documentation to go with it. This takes careful planning, and a development plan. A development plan has three main phases. The first phase is to define what you want to bring to market and its clinical benefits. The second phase is to plan for it, execute it and to document it. However, documenting all the relevant aspects for the product is not an easy feat. There are standards and requirements to adhere to, and proof is needed to validate your claims. Finally, in a third phase, with the correct documentation in place, the product can be submitted for conformity assessment and when approved be put on the market.

2. Ongoing Liability

The dossier is not only for obtaining certification. It’s also required to cover the manufacturer’s liability for the product on the market. After a one-time conformity assessment by a notified body, the dossier may only be reviewed again 3 to 5 years later. For customers, you want your technical documentation to be up-to-date and reflect your state-of-the-art technology. Having such a dossier is important for your customers to ensure their trust in your product, and their relationship with your brand.

3. Unforeseen Issues

We often hear from medical device manufacturers that writing and compiling the required technical documents can help iron out any unforeseen issues. For example, the risk assessments might reveal potential flaws that should be addressed to improve safety and as such contribute to a balanced claim on product benefits versus risks. In this way, the act of writing technical documents has an in-built value add for the medical device and its users.

4. Evidence And Outcomes

Another inherent advantage of preparing a comprehensive dossier is that it provides robust evidence of the design and planning behind your medical device. In some respects, if you haven’t documented it, it hasn’t happened. The dossier is the evidence and outcome of your quality management system (QMS) activities. From making plans and defining criteria, to the execution of testing, the technical dossier evidences your entire QMS system.

5. Supply Chain Visibility

As a manufacturer, you’re responsible for the entire product and how it came to be. That includes your supply chain. This is something that can be easily overlooked. But ensuring the safety and reliability of your product’s components is essential for bringing it to market and keeping it there, as well as keeping customers and patients safe. Compiling the technical information, in compliance with MDR, is a strong reminder to maintain and ensure visibility over your entire supply chain.

Embrace The MDR

Verification is typically not one of the biggest challenges for medical device companies. That’s because almost every manufacturer has already done the required testing prior to compiling their technical dossier – particularly for previously certified products up for recertification. Typically, the main issues with technical documentation are clarity and completeness.

What’s most important for device manufacturers is to embrace the MDR. Matching technical documentation to their QMS, aligned with the requirements of the MDR, and use the format of the relevant Notified Body can make the process of approval and certification much quicker and easier. That means devices will not only get to market faster, they are also more likely to stay there in the long term.

Medical devices and their applications can be highly complex. So it’s inevitable that manufacturers may not have all the answers. In those situations, making use of all available guidance and best practices is key, and also bringing in an expert can help to get it right first time.

PEERCODE Regulatory Consultancy helps medical device companies put together the technical documentation needed to bring their devices to market. Find out how.