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What began in 2012 at the initiative of the European Commission came to an end during the plenary session of April 5th, 2017, with the adoption by the European Parliament of the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR)

New IVDR MDR adopted EU ParliamentTeam NB, the European Association for Medical devices of Notified Bodies, in a note recently published on their website offers a sneak peek of the atmosphere surrounding the session: “There were for each text only one amendment tabled by Nigel Farage and the UKIP, was submitted, asking to reject the trilogue results. These amendments were rejected, which from a procedure point of view is a final endorsement of the text agreed by the Council in March and a closure of the second reading”. This was later confirmed by the acting European Parliament President Rainer Wieland. 

In its Press release, the European Commission “welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.

The changes introduced by the new regulations focus on the following areas:

  • Improve the quality, safety and reliability of medical devices
  • Strengthen transparency of information for consumers
  • Enhance vigilance and market surveillance

The final publication in the Official Journal for both regulations is expected within 4 to 6 weeks.

For Medical Device manufacturers, the adoption of the Medical Device Regulation (MDR) is a reminder that the transition will begin soon and last for 3 years; taking full effect by 2020. LNE/G-MED, a frontrunner for the designation under the new MDR and IVDR, will dedicate its next webinar to the changes introduced by both regulations. Stay tuned!

 

MDSAP Prepare the transition, worldwide market access

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European Medical Device Regulation 2017/745

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager