
EUDAMED Deadline 2026: What to Do Before 27 November
Your devices have been on the EU market for years. They have valid certificates, a technical file and
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.

Your devices have been on the EU market for years. They have valid certificates, a technical file and

In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn

Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements

Malaysia joins MDSAP, expanding global audits. Plus: FDA software guidance, IMDRF PCCP guideline, and Anvisa’s new import process.

Finding the correct technical name for your IVD in Anvisa’s database can be challenging. Learn how to do

What is In Vitro Diagnostics? Discover how IVDs play a vital role in healthcare, the key applications, regulatory

Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
CLIENT VOICES
“
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”

Andreas Kohl
CEO · Andratec
“
“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”

Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)

Clear regulatory direction
The right pathway and priorities for your product.

Fast and responsive support
We act quickly to keep projects moving.

Practical guidance
Actionable advice for your next step.
To provide the best experiences, we use technologies such as cookies to store and/or access device information. Consenting to these technologies allows us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent may negatively affect certain features and functions.