As a manufacturer of an in vitro diagnostic (IVD) medical device, you must ensure you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.
As an EU Notified Body and UK Approved Body our technical specialists have years of experience and can support you through the process of bringing your medical device on to the market.
An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body…”
The definition then outlines the principle or sole purpose of these devices. Under the IVDR, an IVD medical device must have a medical application or purpose. For more clarity on the definition of IVD medical devices, please refer to the IVDR (EU) 2017/746.
Our IVD team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise, and is able to offer CE certification services for IVD medical devices under the EU IVDR and UKCA certification under the UK MDR (2002). Examples of products we cover include:
Use this toolkit to access the key resources you need to prepare for your transition
This resource will help you understand the IVDR conformity assessment routes
Find out how our technical specialists can support your IVD devices business
At BSI we offer training courses tailored to In-Vitro Diagnostics to help support and grow your business.
Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.
