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.

Documents added in February-March 2017

Pharmaceuticals and Medical Device

  • EMA Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, Nov-16
  • FDA Guidance for Industry, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA Jan-17 DRAFT
  • FDA Preamble 21 CFR 4 Postmarketing Safety Reporting for Combination Products, Dec-16


The new ISO 13485:2016 has been published!

"Medical devices - Quality management systems - Requirements for regulatory purposes"

The ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The standard can be ordered from ISO or from the local representation your country.