6 tips for successful MDR compliance

You are on your way to launch your medical software. But then the certification process slows down. The technical documentation you submitted to the Notified Body is incomplete and suddenly, you’re facing unexpected delays as revisions and additional information are required. It’s a common scenario but it doesn’t have to be yours. So, how to have a successful MDR (Medical Device Regulation) compliance process?

TL;DR

Some manufacturers working on medical software make common mistakes, which result in delaying the placement of their product on the EU market. Some ignore compliance through most of the process – for example, skipping early planning for MDR requirements or including implementing a Quality Management System (ISO 13485), and neglect Technical Documentation.

But there are things you can work on to make sure that you avoid those mistakes. What are some of them? You might want to consider compliance an essential part of the development process from the beginning of it. Also, remember that a good Project Manager can glue your team together and keep an eye on maintaining up-to-date documentation.

We recommend looking for team members or a company experienced in developing medical software in line with Medical Device Regulation. This way, you will secure yourself a successful MDR compliance.

Mistakes resulting in MDR certification delays

If you want to market your medical software in the European Union, you must meet requirements set by the Medical Device Regulation (MDR) and other standards (i.e. ISO 13485). It can be a comfortable and swift or tiresome and lengthy process.

In our previous article, we’ve covered the six most common mistakes made by companies wanting to introduce their medical software to the European Union. If you haven’t read it, we advise you to get to know it, as today, we will focus on how to ensure successful MDR compliance.

6 proven strategies for successful MDR compliance

So, how can you stay away from mistakes? We have a couple of suggestions that might help you better orient yourself in the medical software development process.

1. Include MDR compliance from day one

Compliance isn’t the final step – it should be a key part of your strategy from the very beginning, if you want to avoid delaying the process and prevent setbacks in placing your product on the market.

We advise you to work with regulatory affairs specialists familiar with developing medical software under MDR and/or FDA requirements from the earliest stages of your product. Having a person on board who will be on their toes is crucial to ensure your compliance process runs smoothly.

At the beginning of the development process, we recommend mapping out your regulatory milestones the same way you would with product design, development, and marketing.

Also, we advise that you take time to prepare the intended use and ensure you have resources to comply with the appropriate class. Work with your regulatory experts from the beginning to classify your application according to Rule 11 of the MDR and determine its regulatory requirements early on.

2. Plan for the conformity assessment

If your software application is classified as class IIa, IIb or III, you must submit the technical documentation required by MDR Annex II to a notified body for review.

This process can take between 6 and 12 months before... you receive an audit date. During this period, your product is ‘frozen’ – no new features or changes can be introduced until the audit has been passed and the conformity assessment has been finalised.

Therefore, include a waiting period for the various elements in your plan and work with regulatory affair specialists who can give you a hint of what to expect.

3. Find your way to aligning compliance with development

We know that aligning regulations and standards (MDR, IEC 62304, etc.) with Agile methodologies such as Scrum can be challenging. But from our experience – it’s possible.

To bridge this gap, we’ve developed, tested, and implemented our own system of medical software development, which we internally call Scrum 62304. This approach is a result of cooperation between software developers and regulatory affairs specialists.

What makes our system stand out?

We do not omit risk analysis – we start it from the very beginning! Our approach ensures that security and risk management are a crucial and integral part of the product development process. We incorporated preparing documentation to meet the traceability requirements into our developer's workflow. Our software developers consider regulatory deliverables as part of sprint objectives, and regulatory affairs specialists actively participate in regular team meetings.

How to align those processes? We dive deeply into this topic in our newest ebook – From Code Writing to Regulations. The Art of Medical Software Harmony in Scrum. You can get your free copy here.

4. Keep documentation up to date

Keeping your documentation current is essential for a smooth compliance process and ensuring a safe final product that reaches your customers.

To achieve this, it’s important to maintain the Design History File (DHF) for FDA approval or the Technical Documentation for MDR. Leaving everything to be compiled at the end of the process is a costly mistake that could cause delays as it’s nearly impossible to rebuild the documentation.

Additionally, automating documentation tracking can help minimise errors, and conducting internal audits throughout the project will ensure that no critical elements are overlooked and thus, a successful MDR compliance.

5. Have a Project Manager who understands MedTech compliance

Choosing the right Project Manager (PM) is half the battle. Working on a MedTech project isn’t the same as developing any other software. You might want somebody on your team who understands regulatory requirements, the importance of risk analysis, and the difference between the way developers and regulatory affairs specialists work.

Good Project Manager:

• prevents last-minute catching up and avoids delays;

• ensures that compliance is an integral part of the development process, not an afterthought;

• connects Development and Regulatory teams;

• understands the certification pathway and the time required for compliance, ensuring realistic timelines and expectations.

How do you choose the right PM? Look for people with experience in bringing medical devices to life. Think about managers who are not scared by the regulatory requirements and can work in a fast-paced environment.

6. Share the load

You don’t have to face developing medical software in line with MDR alone. Consider working with experienced partners who’ve done this before. Look for companies who have developed medical software in the past, are ISO 13485 certified, and have an in-house regulatory team.

If you are on your way to developing medical software in line with EU or U.S. regulations, we’re here to help you. At Revolve Healthcare, we have experts – software developers, regulatory affairs specialists, project managers, and quality assurance specialists – who are experienced in developing medical software in line with MDR.

Do you ensure successful MDR compliance? We help our clients:

• choose the right class at the beginning of the process,

• avoid rework and costly mistakes,

• build audit-ready documentation without burnout.