The short answer is, yes, it can be.
MDR compliance may not have been expensive in the past, but as the regulations are changing, so is the cost to follow them. The new rules will force the industry to update its existing processes, which could come at a substantial cost. The question is, how much will it cost?
The MDR requires any manufacturer of medical devices for sale in Europe to meet a host of requirements. The regulations cover everything from the quality management system and technical documentation to post-market surveillance and risk management.
Adhering to the new MDR is going to cost medical device manufacturers a lot of money. However, while the price tag may be high, it is not as high as the price to be paid for non-compliance – and that may be more than just money.
When a medical device manufacturer is non-compliant with MDR requirements and fails to properly report adverse events or injuries, that can result in significant fines and penalties.
There is a number of factors that affect the cost of compliance, including the time taken to implement the changes and the type of product you are manufacturing.
A large company that makes various products will likely have more work to do compared with a smaller company that only makes one or two products. However, even small companies will still need to make significant changes if they do not already meet all the requirements.
The new MDR structure and where it will cost you
The MDR document is 174 pages. While that does not look too long, it has enough instructions to cover all and every type of medical device.
The first step in your MDR compliance journey is reading this document and identifying which devices you manufacture or distribute will be affected by the new regulation and how the regulation will affect them.
You may find that some of your devices are already compliant, and some need only minor modifications—this knowledge will help you determine what portion of your budget should go toward ensuring MDR compliance.
There are a few new changes in MDR that will notably take the majority of your team’s effort. Understandably, one of the major MDR changes is the thematic shift towards patient safety. So, you will have to put aside a considerable part of the expenses towards research and development.
Emphasis on the clinical aspects is part of the safety theme of the new regulations. Manufacturers are now required to emphasize both pre and post-market surveillance to ensure the devices are working as they should.
Clinical trials and investigations will need to be conducted prior to marketing. CER updates will also need to be monitored.
As the MDR is distinctively more detailed than the MDD, medical device companies really should train the entire staff on EU MDR requirements even if it seems redundant. It is certainly a necessity for seamless collaboration between teams.
There are also new databases for products and device identification requirements as well that are sure to increase the cost of production. The supply chain costing, along with the production, could increase by 15- 23%. The packaging, leveling, and designs will have to be changed, along with ensuring a steady supply of raw materials.
To ensure medical device optimum performance, quality management systems will need to be in place or updated. Proper quality systems will need to be installed, which includes complete changing or retraining of the staff.
Most companies will have to get their staff recertified to ensure they are up-to-date with all the safety requirements. For manufacturers, this means more workforce, more time, and of course, more resources.
Combining all of that mentioned above, a company can expect the cost to take 10% to 15% of their total revenue.
Cost reduction in new EU MDR
The cost of compliance depends on several factors. The first is whether you have an existing risk management program in place that you can build on. If so, then the cost will be lower. Also, hiring experts for some of the sensitive tasks will reduce costs in the long run.
For example, outsourcing your MDR compliance paperwork gives you access to professionals who will manage all aspects of it for you – from literature review to data management and analysis.
Because you will not need to spend time and resources on hiring, training, and overseeing an entire team for doing paperwork like literature reviews and CER, you will have more time to focus on the development of the device.
Using templates is another technique some manufacturers could benefit from. You could borrow templates or other documentation from MDR experts or organizations that have already been through the process. This will take some more effort on your part but could be worth it if your team is familiar with the process.
While training the staff, instead of thorough training for each team, you can opt for a general workshop/seminar for all. The teams that need certifications can continue from there, and others can be assigned to research or read on their respective tasks.
For example, the team that will work on contacting and managing interactions with the notified body is unlikely to need certifications; a generic seminar on (MDR) medical device regulation should suffice to introduce them to the concept and its significance.
The team members should be able to gain further understanding of the text themselves after the key points are explained to them. This strategy will not work for all teams. For the specific challenging ones, consider hiring experts.
Plan it out
Medical device manufacturers should focus on areas where the effort and resources should go before doing anything else. For example, if you are looking at investing in a new MDR software system or changing processes within your organization, make sure that those changes will actually help you improve compliance and not just collect more data or create more work for people already overwhelmed with tasks. The most important thing to do at this stage is to map out where your risks are and then prioritize actions based on how much they will affect your costs.
Also, consider automation. Automation is key when it comes to improving efficiency and reducing costs. If the goal is to ensure that medical devices are safe and effective, manufacturers should be prepared for the expense.
While a small number of companies will be able to implement MDR without too much of an impact on their businesses, others may find it difficult to adapt to the new regulations. The cost burden will be especially heavy for smaller manufacturers given that they will need to invest in clinical investigations, regulatory expertise, and post-market surveillance.
The truth is that it is impossible to predict how much each company will have to spend on compliance. Any estimate would depend on a variety of factors, such as which companies are involved, the products being manufactured, whether or not there have been any changes made since the application was originally submitted, and so forth.
So, plan the entire process before you start and save cost by automating, hiring experts, using templates, and cutting corners where you can.