December 29, 2020

[FEATURED] Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos

Latest EU survey predicts unprecedented hike in demand for notified body assessments between 2021 and 2024 and insufficient notified body capacity under the Medical Device Regulation.

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November 24, 2020

[FEATURED] Deadlines Needed For Urgent EU MDR Vigilance And Postmarket Surveillance Guidance Documents

Some 46 guidance documents still need to be drafted by the European Commission’s Medical Device Coordination Group before the EU MDR comes into force and time is running out, especially for post-market responsibilities.

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November 17, 2020

[FEATURED] IVDR Implementation Not Yet On Track: What The Diagnostics Sector Needs To Do

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.

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October 20, 2020

[FEATURED] Firms With Rocky MDR Compliance Histories Shut Out Of FDA Adverse Event Program

The US agency has updated its Medical Device Reporting website with information on which products qualify for its Voluntary Malfunction Summary Reporting program for adverse events, and which don’t.

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October 13, 2020

[FEATURED] Requests For Additional Information During EU Audits – What To Expect And How To Avoid Them

A trend toward additional information demands from EU notified bodies risks delays and additional costs. One regulatory expert comments how the EU expectations are now closer to those in the US.

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