The quick answer is that MDR will be delayed by 1 year (26 May 2020).
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 goal of this initiative by the European Commission is to push the deadline of the MDR by one year in order to medical companies to respond to the ongoing COVID 19 Crisis. These companies are involved in medical device design and development quality and regulatory processes, and conformity assessments of medical products which are all affected by the Coronavirus. This is why, the commission, knowing that it would be impossible to focus on the fast-approaching date of application of MDR which was the 26 of May 2020.
When the European Commission agreed and published the proposal, they did not include the proposed changes to Article 120 (3), which confused a few people. People did not know if it was an administrative mistake or if the EU intended that the new date of application should be a ‘soft delay’. They have now clarified this by making sure that Article 120 section 3 C2 would be updated to reflect the proposed 1-year delay.
While this one year delay might sound like a lot of time, the full benefits of this extension will most definitely be hindered by the current measures put in place in multiple countries, such as self-isolation and social distancing. The translation is already a long and tedious process, which will get slowed down by this crisis.
The 1-year delay of the date of the application might be welcomed by multiple stakeholders, as the delay of the MDR will help these companies to ensure the immediate delivery of vital medical devices to healthcare workers and patients. But it is important to remember that this delay does not give that much extra time especially if companies are slowed down due to the economic and health situation. It is not the time to stop working on MDR as it will most definitely be a huge disruption in the medical device industry.
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.