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Regulatory Affairs Update - IVDR

May 17, 2021

Regulatory Affairs

IVDR: Transitional provisions

The new European In-Vitro Diagnostic Medical Devices Regulation (2017/746/EU), also named as “IVDR”, was published by the European Commission in May 2017, marking the start of a 5 years transition period from the current IVDD. During this transition, the IVDR will come into force gradually, so that the effective application date is May 26, 2022. During this transition, the current IVDD (98/79/CE) will remain applicable in every European Country & in the UK.

How is this impacted by Brexit?

Werfen in the UK will act as the “UK Responsible Person” for all Werfen Manufacturers and register the EU IVDD related products on the Medicines and Healthcare products Regulatory Agency (MHRA) portal so they can then be sold in the UK. Registration period is dependent by classification, but all require to be registered by 31st December 2021.

Under the UK Medical Devices Regulations 2002 (UK MDR 2002), IVDR will not be obligatory in the UK as we will move to a UK Conformity Assessment (UKCA) by 1st July 2023. This allows European CE Mark to be replaced on our devices & reagents in England, Scotland & Wales with the UKCA mark. Northern Ireland will continue to use the EU Regulations & the CE Mark.

As our products transition from EU IVDD to IVDR, Werfen will register these products with the MHRA to allow the flow of goods to continue between now and the 1st July 2023 or until they are registered under UKCA.

egulation: main changes for In-Vi

IVDR: Requirements of the Manufacturers and main changes for In-Vitro Diagnostic Medical Devices (IVDs)

IVDs Classification

IVDs shall be classified by the Manufacturer into 4 different classes: Class A, Class B, Class C & Class D. The classification will consider the intended purpose of every device and its related risks.

Class B, C & D devices:

The Conformity Assessment shall be performed through an external Notified Body. The Notified Body will review and assess the quality system of the Manufacturer and the technical files of the products to demonstrate whether the requirements of the IVDR relating to the devices have been fulfilled. At the completion of the assessment, the Notified Body will release the CE Certificate for the involved device. The labelling and the CE Declaration of Conformity prepared by the Manufacturer will report the identification number of the Notified Body.

Information extracted from the Werfen RA booklet.  The complete booklet can be accessed using the PDF link below.

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