IVDs are defined in the new EU IVDR legislation as: “Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment ...

Typically, in the UK, IVD Devices are classified in one of four categories. Class B is the default class that takes in all IVD devices that are not covered specifically in other classification rules.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical ...

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, ...

ADMI expects tax incentives, regulatory reforms & rationalisation of GST from Union Budget 2025: Our Bureau, New Delhi Thursday, January 23, 2025, 08:00 Hrs [IST] The medical devi ...

All of its IVD products are CE-marked and can be commercialized in the EU, and management plans to expand the registration of its products for different device classes in the coming years.

A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). A suite of guidance ...

The Parliamentary Standing Committee on Chemicals and Fertilisers has criticised the ministry for its lack of interest in supporting the in-vitro diagnostic (IVD) devices production in the country ...

In recent years, the in vitro diagnostics (IVD) regulatory landscape in Europe has changed and we are now in the transition from IVD Directive 98/79/EC (IVDD) to In Vitro Medical Devices ...