September 1, 2020

[FEATURED] EU UDI: Commission Explains Basics And Addresses Uncertainties In Q&A Document

Unique Device Identification (UDI) is key to better transparency and traceability in the EU. But this UDI is new to EU medtech manufacturers and complex. The commission has published some helpful pointers.

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August 19, 2020

[FEATURED] European Commission Unlikely To Allow Virtual Audits Under MDR/IVDR In The Short Term

The COVID-19 pandemic has made physical audits of manufacturers unsafe, and demand for auditing is set to reach its peak as the MDR application date looms. While some types of virtual audits are already allowed, others are not, leaving some device manufacturers in limbo.

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August 10, 2020

[FEATURED] Competent Authorities Warn EU Industry Not To Expect All MDR Implementation Tools In Time

Preparing all items needed to support the implementation of the EU’s Medical Device and IVD Regulations in time is going to be impossible. Competent authority expert Thomas W Møller explains how work on a third of implementation tasks still remains to be started.

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August 4, 2020

[FEATURED] What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request?

The timetable for developing harmonized standards under the EU’s Medical Device Regulation was already tight, even with new 2021 MDR application date. But it now looks untenable, even for the most urgently needed standards.

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July 6, 2020

[FEATURED] Devices Containing Ancillary Medicines Likely To Need ‘Near Full Review’ Under MDR

Latest EU guidance highlights the challenges ahead for class III, high-risk, device/drug combinations when preparing for compliance under the tougher requirements of the MDR.

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