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The new EU IVD Regulations (IVDR 2017/746) was formally published in May 2017 and comes into full force from 26 May 2022. The IVDR consolidates and replaces the IVD Directive (MDD) 93/79/EC and is a significant change for the industry. Currently the majority of IVDs do not require Notified Body involvement but under the new IVDR this will change so that most Invitro Diagnostic Devices will require notified body involvement. BSI and LRQA estimate that the re-classification of IVDs will mean 80-90% will no longer be able to self-certify conformity.

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The new EU Medical Device Regulations (MDR 2017/745) was formally published in May 2017 and comes into full force from 26 May 2021. The MDR consolidates and replaces the Medical Devices Directive (MDD) 93/42/EE and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and is more strictly implemented, complex and comprises of 175 pages. There is no grandfathering of devices which means all existing devices will need to be assessed against the MDR and current standards and state of the art.

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