The countdown to May 2020 is on. With less than a year until the new Medical Device Regulation (MDR) laws are enforced, many manufacturers and healthcare companies are battling a series of implementation challenges that have recently emerged.
No matter where you are in your MDR implementation, being aware of what issues could spring up can help keep you on track to meet the deadline.
- Bottlenecks during product review.
MDR has multiplied the workload for notified bodies (the ones responsible for evaluating that products have met the requirements before going to market). So far, this has presented as the largest challenge during the MDR implementation phase.
The reason for the notified body bottleneck is a combination of various factors:
- Fewer notified bodies exist, even though the demand for them is rising. Becoming a notified body is a complicated process, and very few have passed the certification.
- There is a labor shortage. The requirements regarding the qualification of staff have also increased with the new laws. This is another hurdle for notified bodies, as it makes it much harder to hire the necessary experts.
- There is a learning curve. The nitty gritty of MDR and IVDR are complex, so many of the notified bodies are still learning the specifics of what all the new regulations entail.
As a result, new product launches may face delays or existing products that are being reclassified may have to be taken off the market until they can be evaluated by the notified bodies.
- Uncertainty surrounding Brexit
Even today, nobody really knows which Brexit scenario will eventually take place, or how it will look. Similarly, Brexit has created confusion with the MDR and IVDR—particularly around labeling. No matter how Brexit plays out, it will affect medical device manufacturer’s as they strive to comply with MDR and IVDR specifications. The changing regulatory landscapes in both the UK and EU will be affected by Brexit, especially as a “no-deal” Brexit outcome remains a possibility.
- Ongoing ambiguity
If the ambiguity of Brexit wasn’t enough, there is an all-encompassing vagueness and lack of detail for medical devise manufacturers and software companies that are working to meet the changing laws.
Eighteen implementing acts are now expected with the new regulations, but the clarity around them has been widely seen as sluggish. This has resulted in minimal guidance for manufacturers on electronic labeling standards, specifications and many other topics.
Luckily, there are outside resources that can help you navigate the ambiguity and potential challenges. Our ULG team is up to speed on all of the translation action that will need to be taken for labels and IFUs under the new regulations. We bring the capabilities to turn text around quickly and with complete accuracy, so you know that it’s compliant in every language of distribution.
For our roundup of the other 3 implementation challenges, download our free ebook.
To discuss your MDR translation needs, contact us today.
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