August 30, 2022

[FEATURED] No Quick Fix When It Comes To EU MedTech Notified Body Designations

Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.

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August 24, 2022

[FEATURED] European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products Latest Italian Designation Means Germany

The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.

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August 15, 2022

[FEATURED] Latest Italian Designation Means Germany and Italy Are Home to Half EU’s MDR Notified Bodies

While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue..

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August 9, 2022

[FEATURED] European Regulatory Roundup, July 2022: Threat of Ongoing Hurdles Masks Progress

The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for the MDR and IVDR implementation. But with major hurdles ahead, in July it was still the problems and not the successes taking centre stage.

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August 3, 2022

[FEATURED] Multiplex IVDs Position Paper Could Help Relieve Pressure On Notified Bodies

With notified bodies under increasing IVDR workload pressure, their representative associations have come up with one solution that should help rationalize part of their job.

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