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Why experience matters when you choose a Notified Body 

Choosing a Notified Body is one of the most consequential decisions a manufacturer makes. It shapes your timelines, your market access, and your ability to plan with confidence. Experience can help bring greater clarity to a complex regulatory process. Access to reviewers with relevant technical expertise can support more focused discussions and help you better understand what to expect throughout the conformity assessment process. 

As a leading full scope Notified Body under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), BSI reviews devices across every risk class and technology area – from software as a medical device and active implantables to companion diagnostics and combination products.

A Leading Medical Technology Trade Fair 

MEDICA brings together international stakeholders from medicine, technology, industry, and policymaking. The focus is on integrated solutions that address the challenges of modern healthcare systems, and on the exchange of knowledge about their practical implementation. 

It’s where the medical technology community comes to solve shared problems – and where greater regulatory clarity can help manufacturers plan with confidence.  

We'll be there for all four days, celebrating 125 years of BSI, and we’re expanding our global presence and solidifying our position as one of the world’s most trusted Notified Bodies in this field.  

Across the entire medical device sector, we support:  

  • 24 of the 25 leading manufacturers worldwide
  • 83% of small manufacturers  
  • From startups to global market leaders