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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October 5, 2020

[FEATURED] Industry Awaits Commission Ruling On Virtual Audits Under MDR

Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.

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September 29, 2020

[FEATURED] EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures

Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.

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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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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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