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 20, 2020

[FEATURED] FDA To Makers Of EUA Devices: Don’t Forget To Report Adverse Events

Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing any adverse events about the products to the FDA, the US agency says on a new FAQ page.

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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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June 22, 2020

[FEATURED] New EU Association Supports EU Regulatory Compliance Role As Responsibilities Take Shape

Those appointed in the new role of Person Responsible For Regulatory Compliance (PRRC) under the EU MDR are likely to have a tough job ahead. Where can they better understand their remit and find support?

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