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Regulatory Services

Small and Medium Enterprises (SMEs)

We offer a wide range of resources to support SME's by increasing their knowledge on key regulatory topics for market readiness.

SMEs in the MedTech sector

Small and Medium sized Enterprises (SMEs) represent around 95% of medical device manufacturers in Europe. They may find it challenging to navigate the highly regulated MedTech landscape and to place their medical devices on the market.

The main challenges are often the cost, time and resources needed for product certification as well as understanding and implementation of high-level standards required by Regulations.

How BSI supports SMEs

Globally, more than 85% of manufacturers we work with across all regulatory certification services are SMEs. We continue to accept new applications, to refine our supporting tools and to increase the number of SMEs we work with.

BSI fully understands the difficulties that may be encountered throughout the process to place a medical device on the market, from application to conformity assessment, certification and post-market surveillance.

We offer a wide range of resources dedicated to increase your knowledge on key regulatory topics and steps needed to support your market readiness.

Additional guidance

  • Enterprise Europe Network: regulatory requirements and targeted support to MedTech SMEs.

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  • Factsheet Health European Union: actions supporting transition to the new medical devices framework.

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  • EU4Health Programme: financial support, facilitated access and increased preparedness of SMEs.

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  • EU Commission Q&A on Regulation (EU) 2023/607

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Let's shape your organization's future together

Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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