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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June 10, 2020

[FEATURED] Why The EU Urgently Needs A One-Year Delay For The IVDR And EU-Wide Exceptions For IVDs

The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from usual medical device rules was granted recently. But not for IVDs, where the situation is described as “grim.”

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May 31, 2020

[FEATURED] MDR Or MDD: Which Route Should You Choose Now That The MDR Is Delayed?

With the recent EU decision to postpone the Medical Device Regulation by a year, what factors do medtech manufacturers need to consider when deciding the time to submit applications?

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May 20, 2020

[FEATURED] EU COVID-19 Response: Who Is Leading EU’s Decision-Making For Medtech?

The COVID-19 pandemic has meant seismic shifts in the way the EU has been operating to regulate and procure emergency equipment needed on the frontline. Unprecedented changes have been required, but how did the EU achieve this so quickly and how has its reaction impacted central decision-making and how member states work together?

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