COVID-19: Will the European Commission postpone new EU-MDR by 1 year?
The new MDR and IVDR regulations
deadline is set in May of 2020.
Which is a huge challenge for many companies that have to translate their
medical devices in the 24
European languages.
On March 25th, during the Q&A session of a
European Commission meeting, Stefan de
Keersmaecker explained that they were trying to push the deadline of the MDR by
one year. They are trying to do this quickly as the may deadline is approaching
quickly. “This will relieve pressure from national authorities and industry,
and it will allow them to focus fully on urgent priorities related to the
coronavirus”
The proposal should be ready in early April, it then needs approval from
the European Parlement and heads of state in the European Council. If it gets
approved, the deadline should be moved to May 2021.
Many people are worried about the new regulation, Jeffrey B Jump (chairman
and CEO of MedAlliance) wrote in an
article last October (2019) that
“MDR could become the most disruptive factor to hit the European healthcare
market since the start of the Second World War”. He thinks that more than
500,000 products affected by the MDR will not get reapproved by the EU because
of the time and investment needed to translate all of the content in 24
languages. He adds that some companies will have to translate up to 80,000
devices which is a big challenge. He adds “Obtaining a CE mark was simple for
companies to understand and relatively easy to achieve. But the majority of
companies, as well as notified bodies, neither fully understand how to
interpret MDR nor foresee the difficulties of getting it implemented”. All of
this has made some industry experts think that the EU will loose up to 30% of
its medical companies operating on the continent.
With all those challenges coming up and the ongoing crisis, it is safe to
assume that the deadline will be pushed to next year. This gives us all more
time to get ready for this change.
Questions that you may ask yourself:
- Are your devices subject to re-classification?
- Will UDI compliance force the re-labeling of existing devices?
- How should you get ready for the MDR?
Language services providers, like Powerling, understand the new
requirements, will be able to proactively support you in achieving timely
compliance with the new regulation. We have a solid background in medical
device translations and can help you address the challenges of the IFUs and the
new UDI labeling requirements.
Check out our life
sciences page
Contact me at s.chochois@powerling.com