The Impact of MDR on Medical Device Availability in the EU
The EU MDR (Medical Device Regulation) is the new set of regulations for medical device products sold in the EU. The previous regulations, known as MDD (Medical Device Directive), will soon expire. We are in a transition phase as the medical device industry moves to the new regulatory framework.
What do the new regulations mean for medical device suppliers, clinicians, and healthcare administrators in the EU?
One of the most pressing concerns is the availability of medical device products once the transition phase ends. Here’s what you need to know.
MDR Applies to Everything
All medical device products sold in the EU must go through the new MDR approval process. This includes new products coming onto the market and all existing products. In other words, the products you currently use or sell must be re-certified under MDR even if they have been previously approved.
Past Approval Doesn’t Guarantee Ongoing Certification
Previous certification does not mean products will be approved under MDR. The new regulations are more complex in parts, and they are stricter. This alone could impact the availability of some products.
The Deadline is Fast Approaching
The deadline is May 2024. After this date, any product that doesn’t have MDR approval can no longer be sold in the EU.
That’s about 18 months away, so you might think it is plenty of time for medical device manufacturers and EU regulators to certify the products important to your organisation and/or patients. Unfortunately, this isn’t the case.
In June 2022, EU Commissioner Stella Kyriakides said “significant challenges remain” in the transition to MDR, adding that “strong and immediate actions” were required by everyone involved.
To add perspective, when the commissioner made these comments, she was referring to the approximately 25,000 medical device products that will need certification by May 2024. By the summer of 2022, only 1,000 had obtained MDR approval, with about 24,000 still to go.
What Are the Challenges that Could Restrict Availability of Some Medical Device Products?
The fact the process is new so there is a learning curve for everyone involved, exacerbating delays.
Limited Notified Bodies
The limited number of Notified Bodies (NBs) compared to what was available previously is causing delays. NBs assess applications under the new MDR, and they issue approvals.
The situation for NBs is similar to the situation for existing medical device products, i.e., every NB has to be re-certified under the new regulations. That process is taking time.
The increase in complexity of the new regulations is having an impact on the application and approval processes. The EU’s Medical Device Coordination Group (MDCG) published a report in June 2022 that highlighted that, as of December 2021, almost 37 percent of MDR applications were refused because they were incomplete.
In April 2022, 75 percent of NBs said 50 percent of applications were incomplete.
The above points are creating bottlenecks in the approval system and there are fears those bottlenecks will get worse the closer we get to the transition deadline. The current timeline for obtaining MDR approval for both new and existing products is approximately 18 months.
Research into the intentions of medical device companies has found that many are planning to reduce the number of products they sell in the EU.
EU Falling Down the Priority List
Other research has found that companies now intend to prioritise FDA approval. This wasn’t always the case under the previous EU regulatory regime. It was perceived to be a smoother process, so medical device companies would often prioritise EU approval.
According to the research, this situation has switched as the EU process is now perceived to be more complex. Some companies even said they would seek approval in Asian countries before the EU.
If the findings of this research become a reality, many medical device products will be available outside the EU before they are available within it. This will have a knock-on impact on the availability of new medical device products in Europe.
Maintaining Existing Equipment
Further research has highlighted potential problems for EU healthcare organisations looking to obtain parts, consumables, and upgrades to existing medical device products. If companies don’t obtain regulatory approval under the new MDR, they could exit the EU market, making it difficult for healthcare providers to get the support, consumables, parts, and upgrades needed to continue using medical devices safely and effectively.
What Is Being Done to Get on Top of the Situation?
The current situation is far from ideal, but what is being done to ensure medical device suppliers, hospitals, and healthcare facilities can get the products they need?
The MDCG has been looking at this issue. In a recent report, it said:
“Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able to assess all corresponding files within the first months of 2024.”
Then, in August 2022, the MDCG published a position paper outlining additional steps that should be taken to overcome the challenges of making sure medical device products continue to be available after the MDR deadline of May 2024. The solutions proposed include:
- Allowing NBs to conduct hybrid audits as well as providing additional guidance to NBs to help speed up the application assessment and approval process
- Encouraging NBs to increase capacity and streamline internal processes
- Speed up the process to assess and certify NBs to increase the number of NBs that are available
- Require NBs to allocate capacity to SMEs and first-time applicants
- Encourage manufacturers to act on MDR compliance as soon as possible and to “not wait until the end of the transition period”.
- Increase communication between NBs and manufacturers to enhance the level of MDR transition preparedness in the industry
What Should You Do?
The current situation with the new MDR rests with EU decision-makers, NBs, and medical device manufacturers. As a result, there are limited options available for medical device suppliers, hospitals, and other organisations that purchase medical device products in the EU. Some things you can do include:
- Speak to your suppliers to find out their readiness ahead of the MDR deadline and their intentions in terms of the product portfolios they hope to offer in the EU after May 2024.
- Create contingency plans, including identifying alternative suppliers.
At Galt Medical, we are progressing through the MDR certification process. If you are an existing Galt customer in the EU, you can have confidence that our Quality and Regulatory teams are working extensively to ensure that all our products are in compliance with MDR once MDD expires. If you are developing a new product that requires vascular access products or are looking for an alternative supplier and have questions about the implications of MDR, get in touch to speak to one of our team today.