The United States has asked the European Union to push back the compliance deadline for the new EU MDR requirements by three years, citing concerns that the world will lose access to the EU’s $125 million medical device market.
The new EU Medical Device Regulation (MDR) requires all medical device manufacturers doing business in Europe to comply by May 26, 2020. The deadline for a similar requirement for in vitro diagnostic devices (IVDR) is two years later.
Here’s a closer look at the concerns related to the EU MDR and IVDR requirements and what this could mean for manufacturers.
Why Is The U.S. Requesting More Time For EU MDR Compliance?
The EU MDR requires medical device manufacturers to certify both new and existing devices under a more stringent process to show proof of safety and effectiveness.
Because manufacturers of existing devices will need to show additional data to be recertified (and potentially undergo new clinical trials), many are re-evaluating their portfolios to determine which products to pursue first. Due to the cost and time involved in seeking recertification, manufacturers may decide to take some devices off the market.
On July 24, 2019, the U.S. issued a statement to the World Trade Organization’s Committee on Technical Barriers to Trade urging the EU to delay implementation of the MDR and IVDR, citing concerns that both are behind schedule. As a result, numerous medical devices and in vitro diagnostic devices in the EU could be taken off the market.
That could potentially include $20 billion in products supplied by the U.S.
The U.S. cited two specific concerns:
- There is an insufficient number of notified bodies to certify devices under the new regulations.
- The EU has drafted an insufficient number of the implementing acts needed to provide details about how the industry can ensure their products comply with new standards.
The U.S. asked the EU to provide an update on how many of the 58 notified bodies accredited to test and certify products will be approved to operate under the new MDR and IVDR.
The U.S. stated it expects only 12 notified bodies to be operational by the end of 2019, which is not enough to handle all the new regulatory approvals needed.
It also stated that only two of the 18 implementing regulations have been issued, so no one has been able to develop standards to help manufacturers comply with the new requirements.
Additionally, “the MDR and IVDR provisions for warehousing and a grace period, which are intended to provide transitional relief, are insufficient.
“Buyers and producers cannot predict demand, making it difficult to warehouse the right amount of product to meet that demand through the implementation delays,” the U.S. stated in its letter. “Moreover, warehousing is expensive, degradation is common with medical technology and the technology itself can quickly become obsolete.”
If it is not possible to delay the EU MDR and IVDR deadlines, the U.S. is asking to allow legacy products currently deemed safe to be sold on the market until 2024.
What This Means For Medical Device Manufacturers
At this time, there has been no formal response to the letter asking for a three-year implementation delay of the EU MDR and IVDR.
With less than nine months until the first deadline takes effect and a significant amount of work to be done, manufacturers cannot afford to wait in hopes of an extension.
They must take steps now to prepare, starting with a thorough assessment of their device portfolio.
Once they have determined which products need to be recertified first, they should work with an experienced medical device CRO to devise the best plan for data collection.
In some cases, a full-blown clinical trial may be necessary, but there are many other options that could be more cost-effective and efficient. For instance, they may be able to review existing literature or data from a public registry.
As the U.S. stated, the EU MDR and IVDR requirements have created substantial challenges for medical device manufacturers. The regulatory burdens are significant enough that they could result in some devices being taken off the market altogether. However, the driving force behind the EU MDR and IVDR is a commitment to patient safety, so these changes must be taken seriously.
Whether you’ve just begun to consider the implications of these new requirements or you have a clear path forward, IMARC Research can help you prepare for this transition and support you throughout it.