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
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.
What our clients tell us matters most
- Full scope designation under both MDR and IVDR;
- Global teams of clinicians, engineers, and scientists;
- Reviewers with direct experience of your device type;
- Clear, published timelines you can plan around;
- Offices across Europe, the UK, the US, and Asia Pacific; and
- 125 years of shaping standards, not just applying them.
How we can support your certification journey
Wherever you are on your regulatory pathway, our team at Hall 10 F52 can talk you through the next steps.
Certification transfers
Transfer your certification with confidence by maintaining continuity, minimizing disruption, and ensuring a clear, predictable process.
From the initial review onwards, our team will explain what is required, what happens at each stage and what you need to prepare for your transfer to BSI.
Find out more here.
IVDR transitions
Move from the In Vitro Diagnostic Directive to the IVDR with confidence. Our technical team has over 650 years of cumulative experience and has reviewed diagnostics across every class, including companion diagnostics and near-patient testing.
Meet us at booth F52 (Hall 10) to discover how our regulatory services, combined with our world-leading experience, provide efficient pathways to help you achieve your global market access objectives.
We'll help you understand the conformity assessment, offer best practice advice on your technical documentation, and build a realistic timeline against the remaining transition deadlines.
Find out more here.
CE certification for start-ups
Bringing a first device to market is different. You need clarity early, when decisions about design, evidence, and classification are still open.
Our experienced team works with innovators and scale-ups to give regulatory insight on the route to CE marking, so you can plan your funding, your evidence generation, and your launch with confidence.
Find out more here.
