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 ARTICLE] 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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September 22, 2020

[FEATURED] FDA Updated Its eMDR System. Here’s What You Need To Know When Submitting Adverse Events

Executive Summary

The US agency has completed planned modifications to its electronic Medical Device Reporting system – and added an extra field for MDR exemption numbers.

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September 15, 2020

[FEATURED] EU MDR Compliance Will Cost More Than 5% Of Revenues For Half Of Medtechs, Survey Says

Almost half of companies polled on extra resources needed to comply with the EU Medical Device Regulation are preparing for considerable outlay. Manufacturers are also falling short in digital readiness.

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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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