An Orthopaedic and Dental Devices EU Notified Body and UK Approved Body

As an Orthopaedic and Dental Devices manufacturer, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the Medical Device Regulation (MDR) (EU) 2017/745 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.

We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

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