mdr

MDR – Less than one year to go

On 6th June 2019 COCIR, the European trade association representing the medical imaging, radiotherapy, health ICT and electromedical industries, has published a document summarizing the current status in MDR implementation, which still shows little progress in a number of critical aspects.

On 6th June 2019 COCIR, the European trade association representing the medical imaging, radiotherapy, health ICT and electromedical industries, has published a document summarizing the current status in MDR implementation, which still shows little progress in a number of critical aspects.
July 4, 2019

On 6th June 2019 COCIR (European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry), the European trade association representing the medical imaging, radiotherapy, health ICT and electromedical industries, has published a document summarizing the current status in MDR implementation, which still shows little progress in a number of critical aspects. This is shown graphically on a diagram on page 3 of the document.

According to COCIR, “This is a critical period for the entire medical devices regulatory system. If the European Union’s ambition for medical devices are to be realised, the full regulatory framework will have to be in place and functioning. At this moment, it appears that much effort is needed to complete the framework in time. The current delays in implementation make the European Union a less attractive region for investment by medical device manufacturers, and likely increase cost for hospitals and threaten patient access.”

In the COCIR’s updated assessment, the committee also shares several recommendations in order to help addressing the most urgent concerns faced by the EU regulatory system. Here you can read the complete document.

Asphalion closely follows news and movements around the new MDR and IVDR to better assess manufacturers and stakeholders on their implementation.

If you want to have more information, please contact info@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

Christmas season greatings

Season’s Greetings

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting