The new medical device/in-vitro diagnostic regulations are finally adopted in EU

The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally. The revised rules also provide the conditions needed to consolidate the role of the EU in the long-term as a global leader in the sector.

Read the EC Press release:

Block June 7th 10.00-11.30 for the Key2Compliance® Webinar presenting the news and essentials. More information will be posted next week.


April 6, 2017 | Industry: Medical Device